Trial Outcomes & Findings for Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE) (NCT NCT02134028)
NCT ID: NCT02134028
Last Updated: 2022-03-28
Results Overview
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product \[IMP\] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
COMPLETED
PHASE3
2282 participants
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
2022-03-28
Participant Flow
Study was initiated at 365 sites in 27 countries. Participants who successfully completed treatment in studies DRI12544 (NCT01854047),EFC13579 (NCT02414854),EFC13691 (NCT02528214) and PDY14192 (NCT02573233) were eligible to continue their treatment in this extension study LTS12551. Total of 2282 participants were enrolled and treated in this study.
The Total study duration was maximum of 108 weeks for participants enrolled prior to amendment 4 approval and a maximum of 60 weeks for participants enrolled after amendment 4. Following amendment 4 (dated 31 Oct 2016) open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Participant milestones
| Measure |
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 milligram (mg) on Day 1 followed by a subcutaneous (SC) dose of dupilumab 300 mg every 2 weeks (q2w) for 96 weeks in combination with inhaled corticosteroid (ICS) therapy/long-acting beta-agonist (LABA) therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with oral corticosteroids (OCS) and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
111
|
421
|
517
|
1013
|
97
|
90
|
19
|
14
|
|
Overall Study
COMPLETED
|
102
|
379
|
465
|
908
|
83
|
76
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
9
|
42
|
52
|
105
|
14
|
14
|
4
|
3
|
Reasons for withdrawal
| Measure |
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 milligram (mg) on Day 1 followed by a subcutaneous (SC) dose of dupilumab 300 mg every 2 weeks (q2w) for 96 weeks in combination with inhaled corticosteroid (ICS) therapy/long-acting beta-agonist (LABA) therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with oral corticosteroids (OCS) and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
3
|
2
|
1
|
2
|
1
|
0
|
|
Overall Study
Poor compliance to protocol
|
1
|
1
|
3
|
7
|
1
|
1
|
0
|
0
|
|
Overall Study
Other unspecified
|
4
|
22
|
33
|
64
|
8
|
6
|
2
|
1
|
|
Overall Study
Adverse Event
|
3
|
19
|
13
|
32
|
4
|
5
|
1
|
2
|
Baseline Characteristics
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Baseline characteristics by cohort
| Measure |
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Total
n=2282 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
89 Participants
n=42 Participants
|
|
Age, Customized
18-64 years
|
101 Participants
n=5 Participants
|
374 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
826 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
80 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
1917 Participants
n=42 Participants
|
|
Age, Customized
65-74 years
|
8 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
241 Participants
n=42 Participants
|
|
Age, Customized
75-84 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Age, Customized
≥85 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
618 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
1408 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
395 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
874 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
257 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
75 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
844 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
86 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
1922 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)Population: Analysis was performed on exposed population which included participants who actually received at least 1 dose or part of a dose of the IMP in LTS12551 study.
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product \[IMP\] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any treatment emergent SAE
|
0 Participants
|
4 Participants
|
14 Participants
|
42 Participants
|
48 Participants
|
106 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
18 Participants
|
13 Participants
|
88 Participants
|
369 Participants
|
414 Participants
|
789 Participants
|
74 Participants
|
70 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE leading to permanent discontinuation
|
1 Participants
|
2 Participants
|
3 Participants
|
19 Participants
|
12 Participants
|
31 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Criteria for potentially clinically significant vital sign abnormalities: * Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg. * Diastolic blood pressure (DBP): ≤ 45 Adults (≤54 Adolescents) mmHg and DFB ≥ 10 mmHg; ≥ 110 Adults (≥78 Adolescents) mmHg and IFB ≥ 10 mmHg. * Heart rate (HR): ≤ 50 beats per minute (bpm) and DFB ≥ 20 bpm; ≥ 120 bpm and IFB ≥ 20 bpm. * Respiratory rate: less than (\<) 12 breaths/min(b/m); greater than (\>) 20 b/m. * Weight (kg): ≥ 5 percent (%) DFB; ≥ 5% IFB. * Temperature: ≥ 38.0 degree Celsius (°C) rectal/ear/temporal; ≥ 37.5°C oral; ≥ 37.2°C axillary. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg
|
2 Participants
|
0 Participants
|
4 Participants
|
12 Participants
|
19 Participants
|
40 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg
|
1 Participants
|
3 Participants
|
2 Participants
|
17 Participants
|
21 Participants
|
45 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
15 Participants
|
20 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
HR: ≤ 50 & DFB ≥ 20 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
HR: ≥ 120 & IFB ≥ 20 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Respiratory rate: < 12 b/m
|
2 Participants
|
3 Participants
|
5 Participants
|
17 Participants
|
18 Participants
|
24 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Respiratory rate: > 20 b/m
|
4 Participants
|
0 Participants
|
23 Participants
|
104 Participants
|
88 Participants
|
195 Participants
|
18 Participants
|
12 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Weight: ≥ 5% DFB
|
3 Participants
|
3 Participants
|
32 Participants
|
106 Participants
|
146 Participants
|
261 Participants
|
22 Participants
|
29 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Weight: ≥ 5% IFB
|
8 Participants
|
5 Participants
|
45 Participants
|
181 Participants
|
189 Participants
|
378 Participants
|
29 Participants
|
37 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Temperature: ≥ 38.0°C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Temperature: ≥ 37.5°C
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Temperature: ≥ 37.2°C
|
0 Participants
|
0 Participants
|
3 Participants
|
21 Participants
|
4 Participants
|
16 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Criteria for potentially clinically significant abnormalities: * Hemoglobin (Hb): ≤ 115 grams per liter (g/L)(Male \[M\]), ≤ 95 g/L (Female\[ F\]) (\< 100 g/L Adolescents); ≥ 185 g/L (M), ≥ 165 g/L (F) (≥ 200 g/L Adolescents); DFB ≥ 20 g/L. * Hematocrit: ≤ 0.37 volume/volume (v/v) (M); ≤ 0.32 v/v (F) (\<0.32 v/v Adolescents); ≥ 0.55 v/v (M); 0.5 v/v (F) (\>0.47 v/v Adolescents). * RBCs: ≥ 6 Tera/L. * Platelets: \< 100 Giga(G)/L; ≥ 700 G/L. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L)
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L)
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
12 Participants
|
29 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Hb: DFB ≥ 20 g/L
|
0 Participants
|
0 Participants
|
13 Participants
|
41 Participants
|
40 Participants
|
118 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v)
|
0 Participants
|
0 Participants
|
6 Participants
|
19 Participants
|
23 Participants
|
47 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v)
|
0 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
26 Participants
|
36 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
RBCs: ≥ 6 Tera/L
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
15 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Platelets: < 100G/ L
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Platelets: ≥ 700 G/L
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)Population: Analysis was performed on exposed population.
Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Severe Exacerbation Events
|
3 number of events
|
1 number of events
|
62 number of events
|
242 number of events
|
234 number of events
|
437 number of events
|
35 number of events
|
41 number of events
|
SECONDARY outcome
Timeframe: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)Population: Analysis was performed on exposed population.
The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Annualized Event Rate Per Participant-Years for Severe Exacerbation
|
0.149 exacerbation per participant-years
|
0.077 exacerbation per participant-years
|
0.314 exacerbation per participant-years
|
0.330 exacerbation per participant-years
|
0.351 exacerbation per participant-years
|
0.331 exacerbation per participant-years
|
0.302 exacerbation per participant-years
|
0.391 exacerbation per participant-years
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
Week 48
|
0.23 liters
Standard Deviation 0.40
|
0.01 liters
Standard Deviation 0.21
|
0.24 liters
Standard Deviation 0.42
|
0.28 liters
Standard Deviation 0.45
|
0.34 liters
Standard Deviation 0.44
|
0.36 liters
Standard Deviation 0.53
|
0.31 liters
Standard Deviation 0.50
|
0.33 liters
Standard Deviation 0.53
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
Week 96
|
0.14 liters
Standard Deviation 0.41
|
0.01 liters
Standard Deviation 0.12
|
0.22 liters
Standard Deviation 0.44
|
0.27 liters
Standard Deviation 0.46
|
0.33 liters
Standard Deviation 0.44
|
0.31 liters
Standard Deviation 0.47
|
0.36 liters
Standard Deviation 0.66
|
0.25 liters
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
Week 48
|
5.88 percent predicted FEV1
Standard Deviation 10.06
|
1.36 percent predicted FEV1
Standard Deviation 8.35
|
9.21 percent predicted FEV1
Standard Deviation 13.61
|
10.42 percent predicted FEV1
Standard Deviation 14.61
|
11.74 percent predicted FEV1
Standard Deviation 14.27
|
12.16 percent predicted FEV1
Standard Deviation 16.58
|
10.45 percent predicted FEV1
Standard Deviation 15.03
|
12.41 percent predicted FEV1
Standard Deviation 18.27
|
|
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
Week 96
|
4.20 percent predicted FEV1
Standard Deviation 9.60
|
2.00 percent predicted FEV1
Standard Deviation 2.83
|
8.86 percent predicted FEV1
Standard Deviation 14.47
|
10.68 percent predicted FEV1
Standard Deviation 15.10
|
12.53 percent predicted FEV1
Standard Deviation 14.50
|
11.25 percent predicted FEV1
Standard Deviation 14.55
|
13.06 percent predicted FEV1
Standard Deviation 19.57
|
10.00 percent predicted FEV1
Standard Deviation 15.79
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48, and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
Week 96
|
0.08 liters
Standard Deviation 0.29
|
0.05 liters
Standard Deviation 0.40
|
0.16 liters
Standard Deviation 0.47
|
0.22 liters
Standard Deviation 0.52
|
0.27 liters
Standard Deviation 0.48
|
0.25 liters
Standard Deviation 0.50
|
0.38 liters
Standard Deviation 0.82
|
0.22 liters
Standard Deviation 0.42
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
Week 48
|
0.21 liters
Standard Deviation 0.42
|
0.05 liters
Standard Deviation 0.30
|
0.22 liters
Standard Deviation 0.45
|
0.25 liters
Standard Deviation 0.50
|
0.30 liters
Standard Deviation 0.48
|
0.35 liters
Standard Deviation 0.60
|
0.29 liters
Standard Deviation 0.56
|
0.38 liters
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48, and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
Week 48
|
0.23 liters/second
Standard Deviation 0.44
|
0.04 liters/second
Standard Deviation 0.26
|
0.27 liters/second
Standard Deviation 0.55
|
0.31 liters/second
Standard Deviation 0.55
|
0.39 liters/second
Standard Deviation 0.57
|
0.39 liters/second
Standard Deviation 0.66
|
0.34 liters/second
Standard Deviation 0.56
|
0.29 liters/second
Standard Deviation 0.66
|
|
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
Week 96
|
0.19 liters/second
Standard Deviation 0.41
|
0.04 liters/second
Standard Deviation 0.14
|
0.28 liters/second
Standard Deviation 0.57
|
0.32 liters/second
Standard Deviation 0.55
|
0.38 liters/second
Standard Deviation 0.53
|
0.36 liters/second
Standard Deviation 0.61
|
0.42 liters/second
Standard Deviation 0.64
|
0.27 liters/second
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline of parent study, Weeks 24, and 48 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
The ACQ-5 had 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 mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
Week 24
|
-0.96 score on a scale
Standard Deviation 1.03
|
-0.80 score on a scale
Standard Deviation 0.46
|
-1.37 score on a scale
Standard Deviation 0.91
|
-1.48 score on a scale
Standard Deviation 1.10
|
-1.61 score on a scale
Standard Deviation 1.08
|
-1.68 score on a scale
Standard Deviation 1.05
|
-1.09 score on a scale
Standard Deviation 1.10
|
-1.15 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
Week 48
|
-0.89 score on a scale
Standard Deviation 1.02
|
-0.87 score on a scale
Standard Deviation 0.58
|
-1.33 score on a scale
Standard Deviation 1.07
|
-1.57 score on a scale
Standard Deviation 1.11
|
-1.64 score on a scale
Standard Deviation 1.08
|
-1.69 score on a scale
Standard Deviation 1.08
|
-1.21 score on a scale
Standard Deviation 1.00
|
-1.06 score on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: At Weeks 24, and 48 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 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 mean 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 |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
Week 24
|
57.9 percentage of participants
|
69.2 percentage of participants
|
82.7 percentage of participants
|
80.8 percentage of participants
|
84.0 percentage of participants
|
86.5 percentage of participants
|
67.7 percentage of participants
|
70.1 percentage of participants
|
|
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
Week 48
|
60.0 percentage of participants
|
72.7 percentage of participants
|
79.0 percentage of participants
|
82.3 percentage of participants
|
85.7 percentage of participants
|
86.7 percentage of participants
|
75.6 percentage of participants
|
70.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of parent study, Weeks 24, and 48 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed for the participants from Studies DRI12544, EFC13579, and EFC13691 only.
The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
Week 24
|
—
|
—
|
1.07 score on a scale
Standard Deviation 0.99
|
1.28 score on a scale
Standard Deviation 1.24
|
1.38 score on a scale
Standard Deviation 1.15
|
1.38 score on a scale
Standard Deviation 1.16
|
0.99 score on a scale
Standard Deviation 1.10
|
0.97 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
Week 48
|
—
|
—
|
1.07 score on a scale
Standard Deviation 1.13
|
1.40 score on a scale
Standard Deviation 1.19
|
1.39 score on a scale
Standard Deviation 1.17
|
1.40 score on a scale
Standard Deviation 1.18
|
1.06 score on a scale
Standard Deviation 0.98
|
1.00 score on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: At Weeks 24, and 48 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed for the participants from Studies DRI12544, EFC13579, and EFC13691 only.
AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). 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). Higher scores indicated better quality of life.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
Week 24
|
—
|
—
|
67.6 percentage of participants
|
73.6 percentage of participants
|
77.6 percentage of participants
|
77.2 percentage of participants
|
64.2 percentage of participants
|
61.4 percentage of participants
|
|
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
Week 48
|
—
|
—
|
65.0 percentage of participants
|
76.3 percentage of participants
|
77.4 percentage of participants
|
78.4 percentage of participants
|
73.3 percentage of participants
|
68.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension studyPopulation: Analysis was performed on Pharmacokinetics (PK) population which consisted of all the participants who had actually received at least one dose or part of a dose of dupilumab in the LTS12551 study, with at least one non-missing and evaluable pre-dose serum concentration value after the first dose of dupilumab in the LTS12551 study.
For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=515 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1008 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=96 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Baseline
|
—
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.000
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.000
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 1990.640
|
—
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 2286.888
|
—
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.000
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 0
|
—
|
52545.41 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44.678
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.000
|
0.00 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.000
|
—
|
37230.97 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 73.261
|
—
|
40754.49 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.858
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 4
|
23336.89 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50.542
|
56486.58 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45.755
|
46848.70 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43.149
|
40704.77 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.293
|
25847.86 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49.371
|
50566.66 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.104
|
25868.25 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.450
|
48295.93 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.655
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 12
|
49026.51 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41.619
|
55365.35 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.317
|
54467.13 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50.267
|
48155.26 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.353
|
45406.55 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.399
|
55140.49 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.114
|
44064.95 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57.100
|
50904.34 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.233
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 24
|
63080.82 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.224
|
60643.16 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41.617
|
47023.84 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.645
|
49730.56 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.625
|
50984.57 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.744
|
54897.58 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.044
|
57363.72 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57.889
|
44219.42 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.383
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 48
|
24864.79 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.016
|
53320.11 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 46.714
|
46355.26 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.612
|
45919.75 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.932
|
41867.50 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.345
|
41849.96 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.049
|
36219.47 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 67.530
|
36564.41 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.959
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 72
|
40362.88 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.567
|
26383.90 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 120.013
|
44771.52 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.256
|
46842.64 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.335
|
45628.10 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.232
|
46372.55 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57.719
|
60117.76 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.390
|
32029.19 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 66.785
|
|
Serum Concentrations of Dupilumab Over Time Till Week 96
Week 96
|
42360.37 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49.409
|
56378.01 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 7.140
|
42431.08 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.222
|
42661.18 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.658
|
38908.58 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64.633
|
39088.60 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.897
|
49810.65 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65.546
|
19030.70 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 67.237
|
SECONDARY outcome
Timeframe: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)Population: Analysis was performed on ADA population which consisted of all participants who had actually received at least one dose or part of a dose of dupilumab in the LTS12551 study, with at least one pre-dose sample that was assayed successfully using the ADA assay after the first dose of dupilumab in the LTS12551 study.
ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to \> 10,000", where low titer (\< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (\> 10,000).
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=515 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1008 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=95 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antidrug Antibodies (ADA) Response
Treatment-emergent ADA
|
0 percentage of participants
|
7.1 percentage of participants
|
10.8 percentage of participants
|
12.1 percentage of participants
|
9.5 percentage of participants
|
4.5 percentage of participants
|
7.4 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With Antidrug Antibodies (ADA) Response
Treatment-boosted ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
For this analysis, baseline was defined as respective parent study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
n=19 Participants
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
n=14 Participants
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
n=517 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
n=1013 Participants
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
n=97 Participants
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
Week 48
|
-0.066 10^9 cells/L
Standard Deviation 0.181
|
-0.026 10^9 cells/L
Standard Deviation 0.187
|
0.007 10^9 cells/L
Standard Deviation 0.475
|
-0.041 10^9 cells/L
Standard Deviation 0.588
|
-0.096 10^9 cells/L
Standard Deviation 0.428
|
-0.099 10^9 cells/L
Standard Deviation 0.360
|
0.098 10^9 cells/L
Standard Deviation 0.450
|
0.016 10^9 cells/L
Standard Deviation 0.382
|
|
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
Week 96
|
-0.103 10^9 cells/L
Standard Deviation 0.039
|
0.025 10^9 cells/L
Standard Deviation 0.134
|
-0.074 10^9 cells/L
Standard Deviation 0.251
|
-0.081 10^9 cells/L
Standard Deviation 0.562
|
-0.161 10^9 cells/L
Standard Deviation 0.391
|
-0.114 10^9 cells/L
Standard Deviation 0.354
|
-0.051 10^9 cells/L
Standard Deviation 0.399
|
0.083 10^9 cells/L
Standard Deviation 0.642
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
13.26 liters per minute (L/min)
Standard Deviation 76.71
|
22.95 liters per minute (L/min)
Standard Deviation 70.06
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
13.63 liters per minute (L/min)
Standard Deviation 83.88
|
21.69 liters per minute (L/min)
Standard Deviation 77.70
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
4.65 L/min
Standard Deviation 75.00
|
11.97 L/min
Standard Deviation 72.19
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
1.16 L/min
Standard Deviation 79.47
|
10.05 L/min
Standard Deviation 79.47
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
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 ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
-0.49 score on a scale
Standard Deviation 0.78
|
-0.68 score on a scale
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
-0.52 score on a scale
Standard Deviation 0.90
|
-0.76 score on a scale
Standard Deviation 0.81
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48, and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
-0.47 score on a scale
Standard Deviation 0.81
|
-0.72 score on a scale
Standard Deviation 0.85
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
-0.49 score on a scale
Standard Deviation 0.94
|
-0.79 score on a scale
Standard Deviation 0.88
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48, and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. 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 for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
-0.00 inhalations per day
Standard Deviation 3.65
|
0.68 inhalations per day
Standard Deviation 4.80
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
-0.14 inhalations per day
Standard Deviation 4.17
|
-0.82 inhalations per day
Standard Deviation 5.18
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
-0.27 nocturnal awakenings
Standard Deviation 0.54
|
-0.43 nocturnal awakenings
Standard Deviation 0.89
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
-0.29 nocturnal awakenings
Standard Deviation 0.58
|
-0.49 nocturnal awakenings
Standard Deviation 0.96
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Weeks 48 and 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=97 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
Week 48
|
—
|
—
|
55.32 percent change
Standard Deviation 42.98
|
80.23 percent change
Standard Deviation 30.44
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
Week 96
|
—
|
—
|
71.37 percent change
Standard Deviation 29.37
|
88.16 percent change
Standard Deviation 26.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 48 and 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=97 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
Week 48
|
—
|
—
|
64.9 percentage of participants
|
86.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
Week 96
|
—
|
—
|
82.1 percentage of participants
|
94.7 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 48, and 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=97 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=90 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
Week 48
|
—
|
—
|
31.2 percentage of participants
|
59.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
Week 96
|
—
|
—
|
42.9 percentage of participants
|
78.9 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
0.13 score on a scale
Standard Deviation 0.20
|
0.14 score on a scale
Standard Deviation 0.21
|
—
|
—
|
—
|
—
|
|
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
0.12 score on a scale
Standard Deviation 0.18
|
0.13 score on a scale
Standard Deviation 0.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of parent study, Week 48 and Week 96 of this extension studyPopulation: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.
Outcome measures
| Measure |
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Placebo/Dupilumab
n=111 Participants
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544: Dupilumab/Dupilumab
n=421 Participants
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 48
|
—
|
—
|
10.10 score on a scale
Standard Deviation 15.40
|
12.88 score on a scale
Standard Deviation 18.76
|
—
|
—
|
—
|
—
|
|
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
Week 96
|
—
|
—
|
9.90 score on a scale
Standard Deviation 18.92
|
13.95 score on a scale
Standard Deviation 18.81
|
—
|
—
|
—
|
—
|
Adverse Events
Participants From DRI12544 Study Placebo/Dupilumab
Participants From DRI12544 Study Dupilumab/Dupilumab
Participants From EFC13579 Study Placebo/Dupilumab
Participants From EFC13579 Study Dupilumab/Dupilumab
Participants From EFC13691 Study Placebo/Dupilumab
Participants From EFC13691 Study Dupilumab/Dupilumab
Participants From PDY14192 Study Placebo/Dupilumab
Participants From PDY14192 Study Dupilumab/Dupilumab
Serious adverse events
| Measure |
Participants From DRI12544 Study Placebo/Dupilumab
n=111 participants at risk
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544 Study Dupilumab/Dupilumab
n=421 participants at risk
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579 Study Placebo/Dupilumab
n=517 participants at risk
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579 Study Dupilumab/Dupilumab
n=1013 participants at risk
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691 Study Placebo/Dupilumab
n=97 participants at risk
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691 Study Dupilumab/Dupilumab
n=90 participants at risk
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192 Study Placebo/Dupilumab
n=19 participants at risk
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with CS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192 Study Dupilumab/Dupilumab
n=14 participants at risk
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.49%
5/1013 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Congenital, familial and genetic disorders
Odontogenic Cyst
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Endocrine disorders
Goitre
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Eye disorders
Angle Closure Glaucoma
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Eye disorders
Cataract
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Eye disorders
Serous Retinal Detachment
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Incarcerated Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diaphragmatic Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastroenteritis Eosinophilic
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Oesophageal Food Impaction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Retroperitoneum Cyst
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
4/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Immune system disorders
Eosinophilic Granulomatosis With Polyangiitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Abscess Limb
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchopulmonary Aspergillosis Allergic
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Cervicitis
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Herpes Simplex Encephalitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Large Intestine Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Lower Respiratory Tract Infection Bacterial
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Mycobacterium Avium Complex Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.77%
4/517 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.69%
7/1013 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Tonsillitis
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Chemical Peritonitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Post Procedural Constipation
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Pulmonary Contusion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
4/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Ovarian Tumour
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma Of Breast
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular Thyroid Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Adenoma
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Juvenile Melanoma Benign
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Intestine Benign Neoplasm
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Stage I
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Carotid Artery Disease
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Hypertensive Cerebrovascular Disease
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Idiopathic Intracranial Hypertension
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Optic Neuritis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Thalamic Infarction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Iga Nephropathy
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.6%
4/111 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.5%
13/517 • Number of events 13 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.8%
18/1013 • Number of events 19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.6%
5/90 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Perforation
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis Noninfective
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Polyp
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Vesicular
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Social circumstances
Miscarriage Of Partner
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Vascular disorders
Aortic Dilatation
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
Other adverse events
| Measure |
Participants From DRI12544 Study Placebo/Dupilumab
n=111 participants at risk
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From DRI12544 Study Dupilumab/Dupilumab
n=421 participants at risk
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579 Study Placebo/Dupilumab
n=517 participants at risk
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13579 Study Dupilumab/Dupilumab
n=1013 participants at risk
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691 Study Placebo/Dupilumab
n=97 participants at risk
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From EFC13691 Study Dupilumab/Dupilumab
n=90 participants at risk
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192 Study Placebo/Dupilumab
n=19 participants at risk
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with CS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Participants From PDY14192 Study Dupilumab/Dupilumab
n=14 participants at risk
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.59%
6/1013 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Eye disorders
Dry Eye
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.9%
12/421 • Number of events 13 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.7%
9/517 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.3%
13/1013 • Number of events 16 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.1%
4/97 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
5/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.99%
10/1013 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dental Caries
|
0.90%
1/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
6/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.77%
4/517 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.89%
9/1013 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.8%
16/421 • Number of events 20 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
7/517 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.5%
25/1013 • Number of events 27 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.1%
4/97 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
3/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.69%
7/1013 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.1%
13/421 • Number of events 14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.5%
13/517 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
21/1013 • Number of events 23 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
6/421 • Number of events 36 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.5%
8/517 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
14/1013 • Number of events 52 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.97%
5/517 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.3%
13/1013 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
21.1%
4/19 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.4%
10/421 • Number of events 12 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.97%
5/517 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.79%
8/1013 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.2%
5/97 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Erythema
|
23.4%
26/111 • Number of events 102 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
13.1%
55/421 • Number of events 412 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
6.8%
35/517 • Number of events 148 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.9%
50/1013 • Number of events 295 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.2%
5/97 • Number of events 12 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 29 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
42.1%
8/19 • Number of events 21 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
42.9%
6/14 • Number of events 29 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Haematoma
|
3.6%
4/111 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.77%
4/517 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
4/1013 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Haemorrhage
|
4.5%
5/111 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
5/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.97%
5/517 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Oedema
|
3.6%
4/111 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
14/421 • Number of events 84 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.7%
14/517 • Number of events 32 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.5%
15/1013 • Number of events 58 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Pain
|
8.1%
9/111 • Number of events 18 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.3%
18/421 • Number of events 28 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.9%
15/517 • Number of events 40 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
14/1013 • Number of events 51 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Pruritus
|
10.8%
12/111 • Number of events 23 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.8%
16/421 • Number of events 54 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.9%
15/517 • Number of events 36 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.69%
7/1013 • Number of events 20 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.49%
5/1013 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Injection Site Warmth
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 20 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Malaise
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.9%
8/421 • Number of events 12 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.6%
16/1013 • Number of events 20 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
3/90 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
4/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Immune system disorders
Multiple Allergies
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
13.5%
15/111 • Number of events 30 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
19.0%
80/421 • Number of events 135 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
12.2%
63/517 • Number of events 100 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
11.5%
117/1013 • Number of events 181 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
9.3%
9/97 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
15.6%
14/90 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis Viral
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
4/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
5/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.97%
5/517 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.8%
18/1013 • Number of events 21 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
5.4%
6/111 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.7%
7/421 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.9%
10/517 • Number of events 14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.6%
26/1013 • Number of events 31 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Genital Herpes
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Gingivitis
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Influenza
|
4.5%
5/111 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
44/421 • Number of events 52 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.8%
30/517 • Number of events 39 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
6.6%
67/1013 • Number of events 79 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
9.3%
9/97 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.8%
7/90 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.90%
1/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
6/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.7%
17/1013 • Number of events 18 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
24.3%
27/111 • Number of events 47 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
25.9%
109/421 • Number of events 208 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
19.1%
99/517 • Number of events 149 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
18.9%
191/1013 • Number of events 293 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
17.5%
17/97 • Number of events 30 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
17.8%
16/90 • Number of events 22 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
42.9%
6/14 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Oral Candidiasis
|
0.90%
1/111 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
9/421 • Number of events 19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
14/1013 • Number of events 19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis
|
14.4%
16/111 • Number of events 21 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
8.8%
37/421 • Number of events 57 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.0%
26/517 • Number of events 30 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.8%
59/1013 • Number of events 75 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.4%
4/90 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.69%
7/1013 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Pulpitis Dental
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.49%
5/1013 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Respiratory Tract Infection
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.6%
15/421 • Number of events 17 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.97%
5/517 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.8%
18/1013 • Number of events 25 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
11/1013 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Rhinitis
|
6.3%
7/111 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.6%
11/421 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
22/1013 • Number of events 25 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.1%
4/97 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
8.1%
9/111 • Number of events 16 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.8%
33/421 • Number of events 56 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
6.2%
32/517 • Number of events 43 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.9%
50/1013 • Number of events 66 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.4%
4/90 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.2%
18/111 • Number of events 30 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
60/421 • Number of events 87 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
12.6%
65/517 • Number of events 96 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
12.8%
130/1013 • Number of events 213 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
8.2%
8/97 • Number of events 12 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
6.7%
6/90 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
4.5%
5/111 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
6.2%
26/421 • Number of events 31 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
17/517 • Number of events 20 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.1%
42/1013 • Number of events 53 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.1%
4/97 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
3/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.8%
2/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.6%
11/421 • Number of events 15 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.5%
13/517 • Number of events 16 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.0%
30/1013 • Number of events 48 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
5.4%
6/111 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
9.5%
40/421 • Number of events 44 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.4%
28/517 • Number of events 31 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.4%
45/1013 • Number of events 48 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.2%
5/97 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.6%
5/90 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.89%
9/1013 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
14/421 • Number of events 27 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.3%
12/517 • Number of events 13 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
14/1013 • Number of events 18 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
21.4%
3/14 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.7%
7/421 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.3%
12/517 • Number of events 12 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
33/1013 • Number of events 38 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Lip Injury
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.69%
7/1013 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
5/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.9%
10/517 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.69%
7/1013 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Investigations
Epstein-Barr Virus Test Positive
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
9/111 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.5%
23/421 • Number of events 29 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.4%
23/517 • Number of events 29 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
22/1013 • Number of events 22 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.2%
7/97 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
4/111 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
30/421 • Number of events 33 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.4%
23/517 • Number of events 28 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.1%
52/1013 • Number of events 67 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.2%
5/97 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
21.4%
3/14 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.90%
1/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
6/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.90%
1/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
7/517 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.89%
9/1013 • Number of events 10 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
5/111 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
14/421 • Number of events 14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
7/517 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
12/1013 • Number of events 14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
6/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
7/517 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.6%
16/1013 • Number of events 16 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
3/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.8%
2/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.49%
5/1013 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumour Benign
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
2.7%
3/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.9%
12/421 • Number of events 13 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.5%
8/517 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.59%
6/1013 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
11.7%
13/111 • Number of events 14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
11.2%
47/421 • Number of events 141 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
9.1%
47/517 • Number of events 69 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.3%
74/1013 • Number of events 145 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
4.1%
4/97 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.6%
5/90 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
21.1%
4/19 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Migraine
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
7/517 • Number of events 14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.89%
9/1013 • Number of events 9 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
14.3%
2/14 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.71%
3/421 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
4/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Somnolence
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.95%
4/421 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.20%
2/1013 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Anxiety
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
7/517 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.99%
10/1013 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/111 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.4%
6/421 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
6/517 • Number of events 6 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.79%
8/1013 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Leukocyturia
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
4/111 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.8%
16/421 • Number of events 24 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.9%
10/517 • Number of events 12 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
22/1013 • Number of events 29 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.1%
3/97 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.3%
3/90 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/111 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.4%
10/421 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.5%
8/517 • Number of events 8 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
12/1013 • Number of events 23 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.2%
5/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.49%
5/1013 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.7%
3/111 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.1%
13/421 • Number of events 13 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
11/517 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.0%
20/1013 • Number of events 22 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.1%
2/97 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.6%
5/90 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Discomfort
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.39%
2/517 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.1%
1/90 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Increased
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.58%
3/517 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 4 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.48%
2/421 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.97%
5/517 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.89%
9/1013 • Number of events 11 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.10%
1/1013 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rosacea
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pityriasis Alba
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/421 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/111 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.19%
1/517 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.30%
3/1013 • Number of events 3 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/97 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Solar Dermatitis
|
0.90%
1/111 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.24%
1/421 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/517 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/1013 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
1.0%
1/97 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/90 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
7.1%
1/14 • Number of events 1 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
4.5%
5/111 • Number of events 5 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.8%
16/421 • Number of events 19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
3.7%
19/517 • Number of events 20 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.9%
29/1013 • Number of events 37 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
5.2%
5/97 • Number of events 7 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
2.2%
2/90 • Number of events 2 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/19 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
0.00%
0/14 • Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Analysis was performed on safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER