Trial Outcomes & Findings for A Study of Imlifidase in Patients With Guillain-Barré Syndrome (NCT NCT03943589)
NCT ID: NCT03943589
Last Updated: 2025-04-09
Results Overview
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline to Day 360
Results posted on
2025-04-09
Participant Flow
Participant milestones
| Measure |
Imlifidase
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Imlifidase
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Diagnosed with encephalomyelitis
|
1
|
Baseline Characteristics
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
Baseline characteristics by cohort
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 18.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
|
Region of Enrollment
France
|
26 participants
n=5 Participants
|
|
Body mass index (BMI)
|
26.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade
|
6.0 days
Interval 3.0 to 16.0
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.
Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades
|
16.0 days
Interval 8.0 to 92.0
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.
Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) over time
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 4
|
9 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 5
|
9 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 6
|
9 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 7
|
10 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Baseline
|
0 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 2
|
4 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 3
|
5 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 8
|
10 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 15
|
13 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 29
|
14 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 57
|
18 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 92
|
20 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 180
|
23 Participants
|
|
Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided
Day 360
|
24 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded.
Efficacy is assessed as proportion of patients able to run (i.e. Guillain Barré Syndrome disability score \[GBS DS\] ≤1) over time
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Baseline
|
0 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 2
|
0 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 3
|
0 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 4
|
0 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 5
|
1 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 6
|
1 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 7
|
2 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 8
|
4 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 15
|
5 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 29
|
9 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 57
|
11 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 92
|
15 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 180
|
17 Participants
|
|
Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1)
Day 360
|
18 Participants
|
PRIMARY outcome
Timeframe: Baseline until Day 180Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded. 26 patients with data at Day 6 and Day 8, 25 patients with data at Day 15
Efficacy is assessed as Medical Research Council (MRC) sum score over time. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Mean MRC Sum Score Over Time
Day 2
|
42.0 score on a scale
Standard Deviation 14.66
|
|
Mean MRC Sum Score Over Time
Baseline
|
39.1 score on a scale
Standard Deviation 13.88
|
|
Mean MRC Sum Score Over Time
Day 4
|
47.5 score on a scale
Standard Deviation 14.58
|
|
Mean MRC Sum Score Over Time
Day 6
|
49.7 score on a scale
Standard Deviation 13.70
|
|
Mean MRC Sum Score Over Time
Day 8
|
50.0 score on a scale
Standard Deviation 13.80
|
|
Mean MRC Sum Score Over Time
Day 15
|
51.8 score on a scale
Standard Deviation 12.09
|
|
Mean MRC Sum Score Over Time
Day 29
|
49.1 score on a scale
Standard Deviation 17.41
|
|
Mean MRC Sum Score Over Time
Day 57
|
49.0 score on a scale
Standard Deviation 18.39
|
|
Mean MRC Sum Score Over Time
Day 92
|
51.8 score on a scale
Standard Deviation 16.22
|
|
Mean MRC Sum Score Over Time
Day 180
|
54.1 score on a scale
Standard Deviation 12.40
|
PRIMARY outcome
Timeframe: Baseline until Day 180Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded. 26 patients with data at Day 6 and Day 8, 25 patients with data at Day 15
Efficacy is assessed as change in Medical Research Council (MRC) sum score. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Change From Baseline in MRC Sum Score Over Time
Day 2
|
2.9 score on a scale
Standard Deviation 8.23
|
|
Change From Baseline in MRC Sum Score Over Time
Day 4
|
8.4 score on a scale
Standard Deviation 9.19
|
|
Change From Baseline in MRC Sum Score Over Time
Day 6
|
10.3 score on a scale
Standard Deviation 9.81
|
|
Change From Baseline in MRC Sum Score Over Time
Day 8
|
10.7 score on a scale
Standard Deviation 10.21
|
|
Change From Baseline in MRC Sum Score Over Time
Day 15
|
11.2 score on a scale
Standard Deviation 10.42
|
|
Change From Baseline in MRC Sum Score Over Time
Day 29
|
10.0 score on a scale
Standard Deviation 12.99
|
|
Change From Baseline in MRC Sum Score Over Time
Day 57
|
9.9 score on a scale
Standard Deviation 14.59
|
|
Change From Baseline in MRC Sum Score Over Time
Day 92
|
12.7 score on a scale
Standard Deviation 12.96
|
|
Change From Baseline in MRC Sum Score Over Time
Day 180
|
15.0 score on a scale
Standard Deviation 10.62
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded. 24 patients with data at Day 15, 26 patients with data at Day 8, Day 57, Day 92 and day 360.
The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Mean R-ODS Over Time
Baseline
|
23.7 score on a scale
Standard Deviation 15.26
|
|
Mean R-ODS Over Time
Day 8
|
41.9 score on a scale
Standard Deviation 28.01
|
|
Mean R-ODS Over Time
Day 15
|
46.2 score on a scale
Standard Deviation 26.87
|
|
Mean R-ODS Over Time
Day 29
|
52.6 score on a scale
Standard Deviation 33.12
|
|
Mean R-ODS Over Time
Day 57
|
57.2 score on a scale
Standard Deviation 34.54
|
|
Mean R-ODS Over Time
Day 92
|
63.5 score on a scale
Standard Deviation 32.50
|
|
Mean R-ODS Over Time
Day 180
|
70.0 score on a scale
Standard Deviation 29.17
|
|
Mean R-ODS Over Time
Day 360
|
73.8 score on a scale
Standard Deviation 24.36
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: The full analysis set (FAS) consists of data from all dosed patients having a confirmed GBS diagnosis, i.e., patients re-evaluated and having change in diagnosis (incorrectly diagnosed with GBS at trial entry) were excluded. 24 patients with data at Day 15, 26 patients with data at Day 8, Day 57, Day 92 and day 360.
The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Outcome measures
| Measure |
Imlifidase
n=27 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Change From Baseline in R-ODS Over Time
Day 8
|
17.2 score on a scale
Standard Deviation 22.3
|
|
Change From Baseline in R-ODS Over Time
Day 15
|
20.8 score on a scale
Standard Deviation 21.4
|
|
Change From Baseline in R-ODS Over Time
Day 29
|
28.8 score on a scale
Standard Deviation 25.3
|
|
Change From Baseline in R-ODS Over Time
Day 57
|
34.5 score on a scale
Standard Deviation 26.5
|
|
Change From Baseline in R-ODS Over Time
Day 92
|
40.8 score on a scale
Standard Deviation 24.6
|
|
Change From Baseline in R-ODS Over Time
Day 180
|
46.3 score on a scale
Standard Deviation 22.7
|
|
Change From Baseline in R-ODS Over Time
Day 360
|
50.5 score on a scale
Standard Deviation 19.3
|
PRIMARY outcome
Timeframe: Baseline to Day 360Population: Safety analysis set
The number of days the patients were admitted to hospital
Outcome measures
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Days in Hospital
|
32.5 days
Standard Deviation 43.5
|
PRIMARY outcome
Timeframe: Baseline until Day 360Population: Safety analysis set
Efficacy is assessed as time in an intensive care unit (ICU)
Outcome measures
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Time in an ICU
Admitted 0 days
|
18 Participants
|
|
Time in an ICU
Admitted 2-11 days
|
9 Participants
|
|
Time in an ICU
Admitted 106-113 days
|
2 Participants
|
|
Time in an ICU
Admitted 172 days
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline until Day 180Population: Safety analysis set
Outcome measures
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Need for Mechanical Ventilation
Screening
|
0 Participants
|
|
Need for Mechanical Ventilation
Day 1 to Day 90
|
1 Participants
|
|
Need for Mechanical Ventilation
Day 5 to Day 102
|
1 Participants
|
|
Need for Mechanical Ventilation
Day 9 to Day 90 and Day 103 to Day 180
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360Population: Safety analysis set 27 patients with data at Day 92 and Day180, 26 patients with data at Day 8 and Day 360, 25 patients with data at Day 29 and Day 57, 24 patients with data at Day 15.
Quality of Life will be assessed using the EurQol group's EurQol - 5 dimension (EQ-5D) Health questionnaire. The EQ-5D consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical scale, where score 100 is 'The best health you can imagine' and score 0 is the 'The worst health you can imagine'.
Outcome measures
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 92
|
75.2 EQ-5D-5L VAS score
Standard Deviation 23.9
|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 8
|
49.7 EQ-5D-5L VAS score
Standard Deviation 23.7
|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 15
|
61.3 EQ-5D-5L VAS score
Standard Deviation 24.8
|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 29
|
67.3 EQ-5D-5L VAS score
Standard Deviation 21.0
|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 57
|
68.8 EQ-5D-5L VAS score
Standard Deviation 25.1
|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 180
|
78.6 EQ-5D-5L VAS score
Standard Deviation 20.6
|
|
Patient's Health State Over Time as Assessed by EQ VAS
Day 360
|
79.4 EQ-5D-5L VAS score
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: Sampling for PK evaluation was performed for the first 16 patients included in the trial
Cmax=Maximum observed plasma concentration of imlifidase following dosing
Outcome measures
| Measure |
Imlifidase
n=16 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
PK Profile of Imlifidase: Cmax
|
5.5 µg/mL
Geometric Coefficient of Variation 17.0
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: Sampling for PK evaluation was performed for the first 16 patients included in the trial.
Tmax=Time point for maximum observed plasma concentration of imlifidase following dosing
Outcome measures
| Measure |
Imlifidase
n=16 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
PK Profile of Imlifidase: Tmax
|
0.74 hours
Interval 0.47 to 2.07
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: Sampling for PK evaluation was performed for the first 16 patients included in the trial. The time-concentration profile of imlifidase has previously been shown to generally fit a 2-compartment model. 9 out of the 16 patients could be fitted with a 2-compartment model.
AUC=Area under the imlifidase plasma concentration versus time curve
Outcome measures
| Measure |
Imlifidase
n=9 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
PK Profile of Imlifidase: AUC
|
45.0 h×µg/mL
Geometric Coefficient of Variation 54.9
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: Sampling for PK evaluation was performed for the first 16 patients included in the trial. The time-concentration profile of imlifidase has previously been shown to generally fit a 2-compartment model. 9 out of the 16 patients could be fitted with a 2-compartment model. Please note, harmonic mean is used for the t½ α and t½ β.
t1/2=Terminal half-life of imlifidase
Outcome measures
| Measure |
Imlifidase
n=9 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
PK Profile of Imlifidase: t1/2
t½ initial phase (α)
|
1.73 hours
Interval 0.95 to 3.26
|
|
PK Profile of Imlifidase: t1/2
t½ terminal phase (β)
|
30.58 hours
Interval 9.13 to 92.79
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: Sampling for PK evaluation was performed for the first 16 patients included in the trial. The time-concentration profile of imlifidase has previously been shown to generally fit a 2-compartment model. 9 out of the 16 patients could be fitted with a 2-compartment model.
CL=Clearance of imlifidase
Outcome measures
| Measure |
Imlifidase
n=9 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
PK Profile of Imlifidase: CL
|
5.6 mL/h/kg
Geometric Coefficient of Variation 54.9
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: Sampling for PK evaluation was performed for the first 16 patients included in the trial. The time-concentration profile of imlifidase has previously been shown to generally fit a 2-compartment model. 9 out of the 16 patients could be fitted with a 2-compartment model.
V=Volume of distribution
Outcome measures
| Measure |
Imlifidase
n=9 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
PK Profile of Imlifidase: V
Volume of distribution at steady state (Vss)
|
0.2 L/kg
Geometric Coefficient of Variation 41.1
|
|
PK Profile of Imlifidase: V
Volume of distribution during the elimination phase (Vz)
|
0.3 L/kg
Geometric Coefficient of Variation 40.7
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 15Population: 16 patients analyzed at Day 4, Day 5, Day 6 and Day 7 as the protocol was amended after 16 patients were included and a less frequent PD sampling schedule was applied.
The pharmacodynamic (PD) effect of imlifidase is assessed as the elimination of IgG. IgG is cleaved by imlifidase in two steps, the first cut generates single-cleaved IgG (scIgG), and the second cut generates one F(ab')2 fragment and one Fc fragment. The IgG concentration measured in serum using the MSD technology is the sum of intact IgG and scIgG and a decrease in the measured IgG concentration therefore represents complete cleavage of the IgG molecule to Fc and F(ab')2 fragments. For the first 16 patients included in the trial a more frequent PD sampling schedule was conducted. After amending the protocol a less frequent PD sampling schedule was applied.
Outcome measures
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 1, pre-dose
|
10.8 mg/mL
Standard Deviation 4.5
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 2, 24 hours after dose
|
1.3 mg/mL
Standard Deviation 3.5
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 3, before IVIg administration
|
1.6 mg/mL
Standard Deviation 3.5
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 4, before IVIg administration
|
8.6 mg/mL
Standard Deviation 2.3
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 5, before IVIg administration
|
14.3 mg/mL
Standard Deviation 1.9
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 6, before IVIg administration
|
18.1 mg/mL
Standard Deviation 4.0
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 7, before IVIg administration
|
20.8 mg/mL
Standard Deviation 5.5
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 8
|
28.6 mg/mL
Standard Deviation 9.2
|
|
Pharmacodynamics - IgG Level in Serum Over Time
Day 15
|
22.5 mg/mL
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Within 2 hours before imlifidase dose until Day 180Population: 28 patients have data at Day 29, Day 57, Day 92, and Day 180
Anti-imlifidase IgG antibodies (ADA) in serum.
Outcome measures
| Measure |
Imlifidase
n=30 Participants
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 8
|
474.5 mg/L
Standard Deviation 909.0
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 15
|
2811.9 mg/L
Standard Deviation 3772.6
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 29
|
2120.1 mg/L
Standard Deviation 2813.7
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 57
|
1060.3 mg/L
Standard Deviation 1086.5
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 1, pre-dose
|
11.1 mg/L
Standard Deviation 17.1
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 2, 24 hours after dose
|
4.0 mg/L
Standard Deviation 9.6
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 3, before IVIg administration
|
4.5 mg/L
Standard Deviation 12.2
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 92
|
722.1 mg/L
Standard Deviation 806.8
|
|
Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time
Day 180
|
336.0 mg/L
Standard Deviation 318.9
|
Adverse Events
Imlifidase
Serious events: 7 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Imlifidase
n=30 participants at risk
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Investigations
False positive investigation result
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Central nervous system inflammation
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Demyelination
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Escherichia bacteraemia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
Other adverse events
| Measure |
Imlifidase
n=30 participants at risk
One (1) dose of imlifidase, 0.25 mg/kg, will be administered IV over 30 minutes, Day 1.
IVIg, 0.4 g/kg, will be administered for 5 consecutive Days, starting on Day 3 at least 48 h after imlifidase administration.
Imlifidase: All subjects will receive imlifidase (Day 1) prior to standard care IVIg
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
30.0%
9/30 • Number of events 9 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Cheilitis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Faecaloma
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Corona virus infection
|
16.7%
5/30 • Number of events 5 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Pneumonia
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Escherichia urinary tract infection
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Urinary tract infection bacterial
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Cytomegalovirus infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Enterobacter pneumonia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Epstein-Barr virus infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Erysipelas
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Fungal infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Helicobacter infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Klebsiella infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Oral candidiasis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Oral herpes
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Pneumonia pseudomonal
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Tooth infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Infections and infestations
Viral rash
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Facial paralysis
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Presyncope
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Hypersomnia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Ischaemic stroke
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Neuralgia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Piriformis syndrome
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Nervous system disorders
Vocal cord paresis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
C-reactive protein increased
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Liver function test abnormal
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
White blood cell count increased
|
6.7%
2/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Blood albumin decreased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Body temperature increased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Glomerular filtration rate decreased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Haematocrit decreased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Haemoglobin decreased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Haemoglobin urine present
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Oxygen saturation decreased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Protein urine present
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Staphylococcus test positive
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Troponin I increased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Urine ketone body present
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Investigations
Weight decreased
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
5/30 • Number of events 5 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Gout
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Anxiety
|
20.0%
6/30 • Number of events 6 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Hallucination
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Delirium
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Hallucination, visual
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Psychiatric disorders
Intensive care unit delirium
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Vascular disorders
Hypertension
|
20.0%
6/30 • Number of events 7 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Vascular disorders
Venous thrombosis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Vascular disorders
Venous thrombosis limb
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
General disorders
Chills
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
General disorders
Oedema peripheral
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
General disorders
Vessel puncture site phlebitis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectas
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Endocrine disorders
Goitre
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Eye disorders
Eyelid ptosis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Eye disorders
Lagophthalmos
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Eye disorders
Vitreous floaters
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Hepatobiliary disorders
Cholestasis
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Renal and urinary disorders
Prerenal failure
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Skin and subcutaneous tissue disorders
Cutaneous calcification
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Immune system disorders
Drug hypersensitivity
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) were collected for 1 year (i.e., from the timepoint the patient signed the informed consent form (ICF) until Day 360.
AEs were either spontaneously reported, reported in response to an open question, or revealed by observation. A treatment-emergent AE (TEAE) is any AE occurring after imlifidase dosing and within 29 days. The listed non-serious AEs includes both pre-TEAEs, TEAEs and post-TEAEs. 18 SAEs have been reported, 9 of which were treatment-emergent. All SAEs are listed.
|
Additional Information
Vice President Research and Development
Hansa Biopharma AB
Phone: +4646165670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the study, one or more manuscripts for joint publication may be prepared in collaboration between the investigator(s) offered authorship and Hansa Biopharma. Any confidential information relating to imlifidase or the study, including any data and results from the study will be the exclusive property of Hansa Biopharma AB. The investigators and any other persons involved in the trial will protect the confidentiality of the proprietary information belonging to Hansa Biopharma AB
- Publication restrictions are in place
Restriction type: OTHER