Trial Outcomes & Findings for COMparison Between All immunoTherapies for Multiple Sclerosis. (NCT NCT03193866)
NCT ID: NCT03193866
Last Updated: 2025-04-20
Results Overview
Proportion of patients with baseline EDSS \<2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up. Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Recruitment status
COMPLETED
Target enrollment
3526 participants
Primary outcome timeframe
3 years
Results posted on
2025-04-20
Participant Flow
Note that unique patients could contribute to more than one treatment group, both with their first line and second line DMT, or exclusively in the first line or second line DMT group, as based on baseline characteristics. The 'total' automatically summed across groups should be interpreted as the total number of participants in first line DMT and second line DMT, respectively.
Unit of analysis: Treatment Episodes
Participant milestones
| Measure |
RTX (First Line)
Rituximab (First line)
|
IFN (First Line)
Interferons, first line DMT
|
GA (First Line)
Glatiramer acetate, first line DMT
|
DMF (First Line)
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
Natalizumab, first line DMT
|
RTX (Second Line)
Rituximab, as first second line DMT
|
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
Natalizumab, as first second line DMT
|
FGL (Second Line)
Fingolimod, as first second line DMT
|
TFL (Second Line)
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
First Line
STARTED
|
591 591
|
992 992
|
116 116
|
416 416
|
334 334
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
First Line
COMPLETED
|
591 591
|
992 992
|
116 116
|
416 416
|
334 334
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
First Line
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Second Line
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
748 748
|
570 570
|
541 541
|
443 443
|
161 161
|
|
Second Line
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
748 748
|
570 570
|
541 541
|
443 443
|
161 161
|
|
Second Line
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
Baseline characteristics by cohort
| Measure |
RTX (First Line)
n=591 Treatment Episodes
Rituximab (First line)
|
IFN (First Line)
n=992 Treatment Episodes
Interferons, first line DMT
|
GA (First Line)
n=116 Treatment Episodes
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Treatment Episodes
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Treatment Episodes
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Treatment Episodes
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Treatment Episodes
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Treatment Episodes
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Treatment Episodes
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Treatment Episodes
Teriflunomide, as first second line DMT
|
Total
n=4912 Treatment Episodes
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
Sweden
|
591 participants
n=591 Participants • First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
992 participants
n=992 Participants • First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
116 participants
n=116 Participants • First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
416 participants
n=416 Participants • First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
334 participants
n=334 Participants • First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
748 participants
n=748 Participants • Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
570 participants
n=570 Participants • Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
541 participants
n=541 Participants • Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
443 participants
n=443 Participants • Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
161 participants
n=161 Participants • Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
2463 participants
n=2463 Participants • Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
|
|
Year of DMT start
First line
|
2016 year
n=591 Participants • First line and Second line reported in separate rows
|
2013 year
n=992 Participants • First line and Second line reported in separate rows
|
2013 year
n=116 Participants • First line and Second line reported in separate rows
|
2015 year
n=416 Participants • First line and Second line reported in separate rows
|
2014 year
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
2014 year
n=2449 Participants • First line and Second line reported in separate rows
|
|
Year of DMT start
Second line
|
—
|
—
|
—
|
—
|
—
|
2016 year
n=748 Participants • First line and Second line reported in separate rows
|
2015 year
n=570 Participants • First line and Second line reported in separate rows
|
2013 year
n=541 Participants • First line and Second line reported in separate rows
|
2013 year
n=443 Participants • First line and Second line reported in separate rows
|
2015 year
n=161 Participants • First line and Second line reported in separate rows
|
2014 year
n=2463 Participants • First line and Second line reported in separate rows
|
|
Born in Sweden
First line
|
494 Participants
n=591 Participants • First line and Second line reported in separate rows
|
782 Participants
n=992 Participants • First line and Second line reported in separate rows
|
98 Participants
n=116 Participants • First line and Second line reported in separate rows
|
337 Participants
n=416 Participants • First line and Second line reported in separate rows
|
278 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
1989 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Born in Sweden
Second line
|
—
|
—
|
—
|
—
|
—
|
605 Participants
n=748 Participants • First line and Second line reported in separate rows
|
466 Participants
n=570 Participants • First line and Second line reported in separate rows
|
460 Participants
n=541 Participants • First line and Second line reported in separate rows
|
361 Participants
n=443 Participants • First line and Second line reported in separate rows
|
139 Participants
n=161 Participants • First line and Second line reported in separate rows
|
2031 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Education, 12+ years
First line
|
310 Participants
n=591 Participants • First line and Second line reported in separate rows
|
545 Participants
n=992 Participants • First line and Second line reported in separate rows
|
61 Participants
n=116 Participants • First line and Second line reported in separate rows
|
226 Participants
n=416 Participants • First line and Second line reported in separate rows
|
161 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
1303 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Education, 12+ years
Second line
|
—
|
—
|
—
|
—
|
—
|
403 Participants
n=748 Participants • First line and Second line reported in separate rows
|
309 Participants
n=570 Participants • First line and Second line reported in separate rows
|
272 Participants
n=541 Participants • First line and Second line reported in separate rows
|
234 Participants
n=443 Participants • First line and Second line reported in separate rows
|
89 Participants
n=161 Participants • First line and Second line reported in separate rows
|
1307 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Years since MS diagnosis
First line
|
1.3 years
STANDARD_DEVIATION 4.0 • n=591 Participants • First line and Second line reported in separate rows
|
0.9 years
STANDARD_DEVIATION 3.1 • n=992 Participants • First line and Second line reported in separate rows
|
1.7 years
STANDARD_DEVIATION 4.5 • n=116 Participants • First line and Second line reported in separate rows
|
0.6 years
STANDARD_DEVIATION 2.3 • n=416 Participants • First line and Second line reported in separate rows
|
0.5 years
STANDARD_DEVIATION 1.9 • n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
0.9 years
STANDARD_DEVIATION 3.2 • n=2449 Participants • First line and Second line reported in separate rows
|
|
Years since MS diagnosis
Second line
|
—
|
—
|
—
|
—
|
—
|
5.6 years
STANDARD_DEVIATION 5.5 • n=748 Participants • First line and Second line reported in separate rows
|
7.1 years
STANDARD_DEVIATION 5.9 • n=570 Participants • First line and Second line reported in separate rows
|
4.7 years
STANDARD_DEVIATION 4.8 • n=541 Participants • First line and Second line reported in separate rows
|
5.6 years
STANDARD_DEVIATION 4.8 • n=443 Participants • First line and Second line reported in separate rows
|
9.3 years
STANDARD_DEVIATION 6.9 • n=161 Participants • First line and Second line reported in separate rows
|
6.0 years
STANDARD_DEVIATION 5.6 • n=2463 Participants • First line and Second line reported in separate rows
|
|
Any relapse last year
First line
|
367 Participants
n=591 Participants • First line and Second line reported in separate rows
|
648 Participants
n=992 Participants • First line and Second line reported in separate rows
|
62 Participants
n=116 Participants • First line and Second line reported in separate rows
|
265 Participants
n=416 Participants • First line and Second line reported in separate rows
|
252 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
1594 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Any relapse last year
Second line
|
—
|
—
|
—
|
—
|
—
|
254 Participants
n=748 Participants • First line and Second line reported in separate rows
|
120 Participants
n=570 Participants • First line and Second line reported in separate rows
|
288 Participants
n=541 Participants • First line and Second line reported in separate rows
|
172 Participants
n=443 Participants • First line and Second line reported in separate rows
|
30 Participants
n=161 Participants • First line and Second line reported in separate rows
|
864 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
EDSS
First line
|
2.0 units on a scale
STANDARD_DEVIATION 1.3 • n=591 Participants • First line and Second line reported in separate rows
|
1.6 units on a scale
STANDARD_DEVIATION 1.2 • n=992 Participants • First line and Second line reported in separate rows
|
1.4 units on a scale
STANDARD_DEVIATION 1.2 • n=116 Participants • First line and Second line reported in separate rows
|
1.5 units on a scale
STANDARD_DEVIATION 1.1 • n=416 Participants • First line and Second line reported in separate rows
|
2.1 units on a scale
STANDARD_DEVIATION 1.3 • n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
1.7 units on a scale
STANDARD_DEVIATION 1.2 • n=2449 Participants • First line and Second line reported in separate rows
|
|
EDSS
Second line
|
—
|
—
|
—
|
—
|
—
|
2.0 units on a scale
STANDARD_DEVIATION 1.3 • n=748 Participants • First line and Second line reported in separate rows
|
1.6 units on a scale
STANDARD_DEVIATION 1.3 • n=570 Participants • First line and Second line reported in separate rows
|
2.2 units on a scale
STANDARD_DEVIATION 1.4 • n=541 Participants • First line and Second line reported in separate rows
|
1.8 units on a scale
STANDARD_DEVIATION 1.3 • n=443 Participants • First line and Second line reported in separate rows
|
1.8 units on a scale
STANDARD_DEVIATION 1.6 • n=161 Participants • First line and Second line reported in separate rows
|
1.9 units on a scale
STANDARD_DEVIATION 1.4 • n=2463 Participants • First line and Second line reported in separate rows
|
|
MSIS-29 physical
First line
|
1.8 units on a scale
STANDARD_DEVIATION 0.8 • n=591 Participants • First line and Second line reported in separate rows
|
1.6 units on a scale
STANDARD_DEVIATION 0.7 • n=992 Participants • First line and Second line reported in separate rows
|
1.7 units on a scale
STANDARD_DEVIATION 0.6 • n=116 Participants • First line and Second line reported in separate rows
|
1.7 units on a scale
STANDARD_DEVIATION 0.8 • n=416 Participants • First line and Second line reported in separate rows
|
2.0 units on a scale
STANDARD_DEVIATION 0.9 • n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
1.8 units on a scale
STANDARD_DEVIATION 0.8 • n=2449 Participants • First line and Second line reported in separate rows
|
|
Age, Continuous
First line
|
36.9 years
STANDARD_DEVIATION 11.3 • n=591 Participants • First line and Second line reported in separate rows
|
35.8 years
STANDARD_DEVIATION 10.5 • n=992 Participants • First line and Second line reported in separate rows
|
36.9 years
STANDARD_DEVIATION 11.7 • n=116 Participants • First line and Second line reported in separate rows
|
34.4 years
STANDARD_DEVIATION 9.7 • n=416 Participants • First line and Second line reported in separate rows
|
31.6 years
STANDARD_DEVIATION 9.2 • n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
35.3 years
STANDARD_DEVIATION 10.6 • n=2449 Participants • First line and Second line reported in separate rows
|
|
Age, Continuous
Second line
|
—
|
—
|
—
|
—
|
—
|
39.0 years
STANDARD_DEVIATION 10.5 • n=748 Participants • First line and Second line reported in separate rows
|
40.6 years
STANDARD_DEVIATION 10.6 • n=570 Participants • First line and Second line reported in separate rows
|
35.1 years
STANDARD_DEVIATION 9.6 • n=541 Participants • First line and Second line reported in separate rows
|
37.3 years
STANDARD_DEVIATION 9.4 • n=443 Participants • First line and Second line reported in separate rows
|
46.3 years
STANDARD_DEVIATION 9.8 • n=161 Participants • First line and Second line reported in separate rows
|
38.7 years
STANDARD_DEVIATION 10.5 • n=2463 Participants • First line and Second line reported in separate rows
|
|
Sex: Female, Male
First line · Female
|
399 Participants
n=591 Participants • First line and Second line reported in separate rows
|
705 Participants
n=992 Participants • First line and Second line reported in separate rows
|
90 Participants
n=116 Participants • First line and Second line reported in separate rows
|
283 Participants
n=416 Participants • First line and Second line reported in separate rows
|
242 Participants
n=334 Participants • First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
1719 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Sex: Female, Male
First line · Male
|
192 Participants
n=591 Participants • First line and Second line reported in separate rows
|
287 Participants
n=992 Participants • First line and Second line reported in separate rows
|
26 Participants
n=116 Participants • First line and Second line reported in separate rows
|
133 Participants
n=416 Participants • First line and Second line reported in separate rows
|
92 Participants
n=334 Participants • First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
0 Participants
First line and Second line reported in separate rows
|
730 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Sex: Female, Male
Second line · Female
|
—
|
—
|
—
|
—
|
—
|
560 Participants
n=748 Participants • First line and Second line reported in separate rows
|
418 Participants
n=570 Participants • First line and Second line reported in separate rows
|
406 Participants
n=541 Participants • First line and Second line reported in separate rows
|
292 Participants
n=443 Participants • First line and Second line reported in separate rows
|
116 Participants
n=161 Participants • First line and Second line reported in separate rows
|
1792 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Sex: Female, Male
Second line · Male
|
—
|
—
|
—
|
—
|
—
|
188 Participants
n=748 Participants • First line and Second line reported in separate rows
|
152 Participants
n=570 Participants • First line and Second line reported in separate rows
|
135 Participants
n=541 Participants • First line and Second line reported in separate rows
|
151 Participants
n=443 Participants • First line and Second line reported in separate rows
|
45 Participants
n=161 Participants • First line and Second line reported in separate rows
|
671 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
MSIS-29 physical
Second line
|
—
|
—
|
—
|
—
|
—
|
1.7 units on a scale
STANDARD_DEVIATION 0.8 • n=748 Participants • First line and Second line reported in separate rows
|
1.6 units on a scale
STANDARD_DEVIATION 0.7 • n=570 Participants • First line and Second line reported in separate rows
|
1.9 units on a scale
STANDARD_DEVIATION 0.9 • n=541 Participants • First line and Second line reported in separate rows
|
1.7 units on a scale
STANDARD_DEVIATION 0.8 • n=443 Participants • First line and Second line reported in separate rows
|
1.7 units on a scale
STANDARD_DEVIATION 0.7 • n=161 Participants • First line and Second line reported in separate rows
|
1.8 units on a scale
STANDARD_DEVIATION 0.8 • n=2463 Participants • First line and Second line reported in separate rows
|
|
MSIS-29 psychological
First line
|
2.4 units on a scale
STANDARD_DEVIATION 1.0 • n=591 Participants • First line and Second line reported in separate rows
|
2.2 units on a scale
STANDARD_DEVIATION 0.9 • n=992 Participants • First line and Second line reported in separate rows
|
2.6 units on a scale
STANDARD_DEVIATION 0.9 • n=116 Participants • First line and Second line reported in separate rows
|
2.3 units on a scale
STANDARD_DEVIATION 1.0 • n=416 Participants • First line and Second line reported in separate rows
|
2.6 units on a scale
STANDARD_DEVIATION 1.0 • n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
2.4 units on a scale
STANDARD_DEVIATION 1.0 • n=2449 Participants • First line and Second line reported in separate rows
|
|
MSIS-29 psychological
Second line
|
—
|
—
|
—
|
—
|
—
|
2.2 units on a scale
STANDARD_DEVIATION 1.0 • n=748 Participants • First line and Second line reported in separate rows
|
2.0 units on a scale
STANDARD_DEVIATION 0.9 • n=570 Participants • First line and Second line reported in separate rows
|
2.4 units on a scale
STANDARD_DEVIATION 1.0 • n=541 Participants • First line and Second line reported in separate rows
|
2.2 units on a scale
STANDARD_DEVIATION 0.9 • n=443 Participants • First line and Second line reported in separate rows
|
2.1 units on a scale
STANDARD_DEVIATION 1.0 • n=161 Participants • First line and Second line reported in separate rows
|
2.2 units on a scale
STANDARD_DEVIATION 1.0 • n=2463 Participants • First line and Second line reported in separate rows
|
|
Serious infection
First line
|
15 Participants
n=591 Participants • First line and Second line reported in separate rows
|
21 Participants
n=992 Participants • First line and Second line reported in separate rows
|
1 Participants
n=116 Participants • First line and Second line reported in separate rows
|
7 Participants
n=416 Participants • First line and Second line reported in separate rows
|
16 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
60 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Serious infection
Second line
|
—
|
—
|
—
|
—
|
—
|
21 Participants
n=748 Participants • First line and Second line reported in separate rows
|
17 Participants
n=570 Participants • First line and Second line reported in separate rows
|
21 Participants
n=541 Participants • First line and Second line reported in separate rows
|
12 Participants
n=443 Participants • First line and Second line reported in separate rows
|
6 Participants
n=161 Participants • First line and Second line reported in separate rows
|
77 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Cancer
First line
|
4 Participants
n=591 Participants • First line and Second line reported in separate rows
|
10 Participants
n=992 Participants • First line and Second line reported in separate rows
|
3 Participants
n=116 Participants • First line and Second line reported in separate rows
|
4 Participants
n=416 Participants • First line and Second line reported in separate rows
|
3 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
24 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Cancer
Second line
|
—
|
—
|
—
|
—
|
—
|
10 Participants
n=748 Participants • First line and Second line reported in separate rows
|
10 Participants
n=570 Participants • First line and Second line reported in separate rows
|
2 Participants
n=541 Participants • First line and Second line reported in separate rows
|
6 Participants
n=443 Participants • First line and Second line reported in separate rows
|
7 Participants
n=161 Participants • First line and Second line reported in separate rows
|
35 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Antidepressant use
First line
|
88 Participants
n=591 Participants • First line and Second line reported in separate rows
|
98 Participants
n=992 Participants • First line and Second line reported in separate rows
|
25 Participants
n=116 Participants • First line and Second line reported in separate rows
|
64 Participants
n=416 Participants • First line and Second line reported in separate rows
|
35 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
310 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Antidepressant use
Second line
|
—
|
—
|
—
|
—
|
—
|
124 Participants
n=748 Participants • First line and Second line reported in separate rows
|
92 Participants
n=570 Participants • First line and Second line reported in separate rows
|
108 Participants
n=541 Participants • First line and Second line reported in separate rows
|
81 Participants
n=443 Participants • First line and Second line reported in separate rows
|
42 Participants
n=161 Participants • First line and Second line reported in separate rows
|
447 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
MACE
First line
|
9 Participants
n=591 Participants • First line and Second line reported in separate rows
|
10 Participants
n=992 Participants • First line and Second line reported in separate rows
|
4 Participants
n=116 Participants • First line and Second line reported in separate rows
|
2 Participants
n=416 Participants • First line and Second line reported in separate rows
|
3 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
28 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
MACE
Second line
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=748 Participants • First line and Second line reported in separate rows
|
6 Participants
n=570 Participants • First line and Second line reported in separate rows
|
5 Participants
n=541 Participants • First line and Second line reported in separate rows
|
1 Participants
n=443 Participants • First line and Second line reported in separate rows
|
4 Participants
n=161 Participants • First line and Second line reported in separate rows
|
22 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Arrhythmia
First line
|
10 Participants
n=591 Participants • First line and Second line reported in separate rows
|
7 Participants
n=992 Participants • First line and Second line reported in separate rows
|
0 Participants
n=116 Participants • First line and Second line reported in separate rows
|
2 Participants
n=416 Participants • First line and Second line reported in separate rows
|
2 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
21 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Arrhythmia
Second line
|
—
|
—
|
—
|
—
|
—
|
11 Participants
n=748 Participants • First line and Second line reported in separate rows
|
5 Participants
n=570 Participants • First line and Second line reported in separate rows
|
8 Participants
n=541 Participants • First line and Second line reported in separate rows
|
6 Participants
n=443 Participants • First line and Second line reported in separate rows
|
1 Participants
n=161 Participants • First line and Second line reported in separate rows
|
31 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
|
Diabetes
First line
|
13 Participants
n=591 Participants • First line and Second line reported in separate rows
|
17 Participants
n=992 Participants • First line and Second line reported in separate rows
|
2 Participants
n=116 Participants • First line and Second line reported in separate rows
|
4 Participants
n=416 Participants • First line and Second line reported in separate rows
|
7 Participants
n=334 Participants • First line and Second line reported in separate rows
|
—
|
—
|
—
|
—
|
—
|
43 Participants
n=2449 Participants • First line and Second line reported in separate rows
|
|
Diabetes
Second line
|
—
|
—
|
—
|
—
|
—
|
17 Participants
n=748 Participants • First line and Second line reported in separate rows
|
12 Participants
n=570 Participants • First line and Second line reported in separate rows
|
6 Participants
n=541 Participants • First line and Second line reported in separate rows
|
5 Participants
n=443 Participants • First line and Second line reported in separate rows
|
2 Participants
n=161 Participants • First line and Second line reported in separate rows
|
42 Participants
n=2463 Participants • First line and Second line reported in separate rows
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
Proportion of patients with baseline EDSS \<2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up. Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline
First line
|
20 Participants
|
50 Participants
|
5 Participants
|
14 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline
Second line
|
—
|
—
|
—
|
—
|
—
|
18 Participants
|
25 Participants
|
19 Participants
|
19 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Proportion of patients with baseline EDSS ≥2.5 experiencing 12 months confirmed EDSS increase of 1 point among those over 3 years of follow up Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline
Second line
|
—
|
—
|
—
|
—
|
—
|
50 Participants
|
57 Participants
|
47 Participants
|
37 Participants
|
9 Participants
|
|
Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline
First line
|
50 Participants
|
111 Participants
|
9 Participants
|
30 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Change in the MSIS-29 physical subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) physical subscale measures patient-reported physical impact of multiple sclerosis. Scale range: Minimum score: 1 (least impact). Maximum score: 5 (highest impact). Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Disease-related Impact on Daily Life, Physical
First line
|
-1.4 units on a scale
Standard Deviation 16.6
|
1.1 units on a scale
Standard Deviation 16.2
|
-4.8 units on a scale
Standard Deviation 17.7
|
-1.2 units on a scale
Standard Deviation 16.1
|
-6.3 units on a scale
Standard Deviation 18.0
|
—
|
—
|
—
|
—
|
—
|
|
Disease-related Impact on Daily Life, Physical
Second line
|
—
|
—
|
—
|
—
|
—
|
-0.3 units on a scale
Standard Deviation 14.5
|
-0.5 units on a scale
Standard Deviation 13.3
|
-2.1 units on a scale
Standard Deviation 16.4
|
-1.3 units on a scale
Standard Deviation 14.3
|
2.9 units on a scale
Standard Deviation 16.5
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Change in the MSIS-29 psychological subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) psychological subscale measures patient-reported psychological impact of multiple sclerosis. Scale range: Minimum score: 1 (least impact). Maximum score: 5 (highest impact). Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Disease-related Impact on Daily Life, Psychological
First line
|
-8.5 units on a scale
Standard Deviation 21.3
|
-5.1 units on a scale
Standard Deviation 20.7
|
-23.1 units on a scale
Standard Deviation 23.8
|
-6.8 units on a scale
Standard Deviation 20.7
|
-12.2 units on a scale
Standard Deviation 22.3
|
—
|
—
|
—
|
—
|
—
|
|
Disease-related Impact on Daily Life, Psychological
Second line
|
—
|
—
|
—
|
—
|
—
|
-3.7 units on a scale
Standard Deviation 19.5
|
-1.7 units on a scale
Standard Deviation 19.3
|
-6.1 units on a scale
Standard Deviation 20.5
|
-4.7 units on a scale
Standard Deviation 19.5
|
-0.3 units on a scale
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Comparison of mean number of relapses per year between the different treatments
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Annualized Relapse Rate
Second line
|
—
|
—
|
—
|
—
|
—
|
0.09 percentage of relapses
Standard Deviation 0.34
|
0.22 percentage of relapses
Standard Deviation 0.54
|
0.30 percentage of relapses
Standard Deviation 0.67
|
0.30 percentage of relapses
Standard Deviation 0.72
|
0.25 percentage of relapses
Standard Deviation 0.61
|
|
Annualized Relapse Rate
First line
|
0.08 percentage of relapses
Standard Deviation 0.31
|
0.59 percentage of relapses
Standard Deviation 0.94
|
0.47 percentage of relapses
Standard Deviation 0.73
|
0.26 percentage of relapses
Standard Deviation 0.53
|
0.26 percentage of relapses
Standard Deviation 0.63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Proportion remaining on the index DMT after 3 years
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Remaining on Drug
First line
|
527 Participants
|
300 Participants
|
40 Participants
|
191 Participants
|
167 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Remaining on Drug
Second line
|
—
|
—
|
—
|
—
|
—
|
662 Participants
|
307 Participants
|
299 Participants
|
260 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Comparison of yearly increase in mean EDSS between the different treatments Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Increase in EDSS
Second line
|
—
|
—
|
—
|
—
|
—
|
-0.0 units on a scale
Standard Deviation 0.9
|
0.1 units on a scale
Standard Deviation 0.9
|
-0.1 units on a scale
Standard Deviation 1.1
|
0.1 units on a scale
Standard Deviation 1.0
|
0.3 units on a scale
Standard Deviation 0.9
|
|
Increase in EDSS
First line
|
-0.2 units on a scale
Standard Deviation 1.2
|
0.1 units on a scale
Standard Deviation 1.2
|
0.2 units on a scale
Standard Deviation 1.2
|
-0.2 units on a scale
Standard Deviation 1.1
|
-0.4 units on a scale
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Comparison of yearly proportion of patients with at least 1 step increase in EDSS between the different treatments Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients With at Least 1 Step Increase in EDSS
First line
|
108 Participants
|
272 Participants
|
43 Participants
|
83 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Patients With at Least 1 Step Increase in EDSS
Second line
|
—
|
—
|
—
|
—
|
—
|
135 Participants
|
114 Participants
|
117 Participants
|
93 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Comparison of yearly proportion of patients with No Evidence of Disease Activity (NEDA) -2 (free of exacerbations, new/enlarged T2-lesions and occurrence of CEL) between the treatments. Lower NEDA-2 scores indicate better outcomes. Higher NEDA-2 scores indicate worse outcomes.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients With No Evidence of Disease Activity (NEDA) -2
First line
|
483 Participants
|
348 Participants
|
44 Participants
|
235 Participants
|
208 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Patients With No Evidence of Disease Activity (NEDA) -2
Second line
|
—
|
—
|
—
|
—
|
—
|
638 Participants
|
356 Participants
|
326 Participants
|
226 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Comparison of yearly proportion of patients with NEDA-3 (NEDA-2 plus no confirmed worsening of EDSS from baseline). Lower NEDA-3 scores indicate better outcomes. Higher NEDA-3 scores indicate worse outcomes.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients With NEDA-3
Second line
|
—
|
—
|
—
|
—
|
—
|
619 Participants
|
339 Participants
|
314 Participants
|
220 Participants
|
94 Participants
|
|
Proportion of Patients With NEDA-3
First line
|
467 Participants
|
340 Participants
|
43 Participants
|
232 Participants
|
204 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
Comparison of health-related quality of life measured by the European Quality of Life Five Dimensions (EQ-5D). Higher values indicate better health, and lower values indicate poorer health. The maximum theoretical value is 1. While there is no fixed minimum, scores can fall below 0, indicating health states worse than death. In this study, scores ranged from -0.59 to 1, which represent clinically relevant ranges of values.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Quality of Life Assessments
First line
|
0.77 units on a scale
Standard Deviation 0.24
|
0.77 units on a scale
Standard Deviation 0.24
|
0.74 units on a scale
Standard Deviation 0.26
|
0.81 units on a scale
Standard Deviation 0.22
|
0.76 units on a scale
Standard Deviation 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Quality of Life Assessments
Second line
|
—
|
—
|
—
|
—
|
—
|
0.76 units on a scale
Standard Deviation 0.24
|
0.81 units on a scale
Standard Deviation 0.22
|
0.74 units on a scale
Standard Deviation 0.27
|
0.79 units on a scale
Standard Deviation 0.22
|
0.76 units on a scale
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
Comparison of fatigue measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC). The fatigue scale for motor and cognitive functions (FSMC) scale range: Minimum score: 20. Maximum score: 100. Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Fatigue
First line
|
55.1 units on a scale
Standard Deviation 22.9
|
52.1 units on a scale
Standard Deviation 23.0
|
55.7 units on a scale
Standard Deviation 22.2
|
48.3 units on a scale
Standard Deviation 23.0
|
53.2 units on a scale
Standard Deviation 23.2
|
—
|
—
|
—
|
—
|
—
|
|
Fatigue
Second line
|
—
|
—
|
—
|
—
|
—
|
53.5 units on a scale
Standard Deviation 23.0
|
49.7 units on a scale
Standard Deviation 21.6
|
55.9 units on a scale
Standard Deviation 23.0
|
49.3 units on a scale
Standard Deviation 22.8
|
53.1 units on a scale
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
Comparison of patient satisfaction with their treatment using the Treatment Satisfaction Questionnaire (TSQ), items 1-9, restricted to patients remaining on index DMT at 3 years. The Treatment Satisfaction Questionnaire (TSQ), items 1-9 scale range: Minimum score: 0. Maximum score: 100. Lower scores indicate worse outcomes. Higher scores indicate better outcomes.
Outcome measures
| Measure |
RTX (First Line)
n=544 Participants
Rituximab (First line)
|
IFN (First Line)
n=282 Participants
Interferons, first line DMT
|
GA (First Line)
n=36 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=191 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=168 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=692 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=309 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=303 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=263 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=77 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Satisfaction
Second line
|
—
|
—
|
—
|
—
|
—
|
49.5 units on a scale
Standard Deviation 7.2
|
49.0 units on a scale
Standard Deviation 6.7
|
49.5 units on a scale
Standard Deviation 6.7
|
51.8 units on a scale
Standard Deviation 6.3
|
51.6 units on a scale
Standard Deviation 6.3
|
|
Treatment Satisfaction
First line
|
50.1 units on a scale
Standard Deviation 6.8
|
44.3 units on a scale
Standard Deviation 7.7
|
42.8 units on a scale
Standard Deviation 8.3
|
48.3 units on a scale
Standard Deviation 7.1
|
49.5 units on a scale
Standard Deviation 6.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Rate of serious infections, defined as hospitalizations where the main diagnosis included an ICD-10 diagnosis code in the national patient register in the 3 years after initiating index DMT
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Serious Infections
First line
|
12.7 infections per 1000 person-years
Interval 7.9 to 19.2
|
6.8 infections per 1000 person-years
Interval 4.2 to 10.5
|
5.8 infections per 1000 person-years
Interval 0.7 to 21.1
|
9.8 infections per 1000 person-years
Interval 5.0 to 17.1
|
12.2 infections per 1000 person-years
Interval 6.3 to 21.2
|
—
|
—
|
—
|
—
|
—
|
|
Rate of Serious Infections
Second line
|
—
|
—
|
—
|
—
|
—
|
20.2 infections per 1000 person-years
Interval 14.7 to 27.2
|
5.9 infections per 1000 person-years
Interval 2.8 to 10.9
|
6.2 infections per 1000 person-years
Interval 3.0 to 11.5
|
10.7 infections per 1000 person-years
Interval 5.9 to 18.0
|
14.9 infections per 1000 person-years
Interval 6.0 to 30.6
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Rate of MACE, defined as acute coronary syndrome, stroke or death from any cardiovascular cause based on corresponding ICD-codes in the national patient and cause of death registries in the 3 years after initiating index DMT
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Major Adverse Cardiovascular Events (MACE)
Second line
|
—
|
—
|
—
|
—
|
—
|
1.3 MACE per 1000 person-years
Interval 0.3 to 3.9
|
0.6 MACE per 1000 person-years
Interval 0.0 to 3.3
|
1.2 MACE per 1000 person-years
Interval 0.1 to 4.5
|
0.0 MACE per 1000 person-years
Interval 0.0 to 2.8
|
4.2 MACE per 1000 person-years
Interval 0.5 to 15.1
|
|
Rate of Major Adverse Cardiovascular Events (MACE)
First line
|
1.7 MACE per 1000 person-years
Interval 0.4 to 5.0
|
1.4 MACE per 1000 person-years
Interval 0.4 to 3.5
|
0.0 MACE per 1000 person-years
Interval 0.0 to 10.6
|
0.8 MACE per 1000 person-years
Interval 0.0 to 4.5
|
0.0 MACE per 1000 person-years
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: First line and Second line reported in separate rows
\- Rate of incident invasive cancer, defined as invasive cancers based on corresponding ICD-codes in the national cancer registry in the 3 years after initiating index DMT.
Outcome measures
| Measure |
RTX (First Line)
n=591 Participants
Rituximab (First line)
|
IFN (First Line)
n=992 Participants
Interferons, first line DMT
|
GA (First Line)
n=116 Participants
Glatiramer acetate, first line DMT
|
DMF (First Line)
n=416 Participants
Dimethyl fumarate, first line DMT
|
NTZ (First Line)
n=334 Participants
Natalizumab, first line DMT
|
RTX (Second Line)
n=748 Participants
Rituximab, as first second line DMT
|
DMF (Second Line)
n=570 Participants
Dimethyl fumarate, as first second line DMT
|
NTZ (Second Line)
n=541 Participants
Natalizumab, as first second line DMT
|
FGL (Second Line)
n=443 Participants
Fingolimod, as first second line DMT
|
TFL (Second Line)
n=161 Participants
Teriflunomide, as first second line DMT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Invasive Cancer
First line
|
0.6 invasive cancer per 1000 person-years
Interval 0.0 to 3.2
|
2.4 invasive cancer per 1000 person-years
Interval 1.0 to 4.9
|
2.9 invasive cancer per 1000 person-years
Interval 0.1 to 16.2
|
0.0 invasive cancer per 1000 person-years
Interval 0.0 to 3.0
|
3.0 invasive cancer per 1000 person-years
Interval 0.6 to 8.8
|
—
|
—
|
—
|
—
|
—
|
|
Rate of Invasive Cancer
Second line
|
—
|
—
|
—
|
—
|
—
|
1.3 invasive cancer per 1000 person-years
Interval 0.3 to 3.9
|
3.0 invasive cancer per 1000 person-years
Interval 1.0 to 6.9
|
1.2 invasive cancer per 1000 person-years
Interval 0.1 to 4.5
|
4.6 invasive cancer per 1000 person-years
Interval 1.7 to 9.9
|
0.0 invasive cancer per 1000 person-years
Interval 0.0 to 7.7
|
Adverse Events
RTX (First or Second Line)
Serious events: 43 serious events
Other events: 0 other events
Deaths: 1 deaths
IFN (First Line)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
GA (First Line)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DMF (First or Second Line)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
NTZ (First or Second Line)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
FGL (First Line)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
TFL (First Line)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
RTX (First or Second Line)
n=1184 participants at risk
Rituximab, as first line or second line DMT
|
IFN (First Line)
n=884 participants at risk
Interferons, first line DMT
|
GA (First Line)
n=97 participants at risk
Glatiramer acetate, first line DMT
|
DMF (First or Second Line)
n=870 participants at risk
Dimethyl fumarate, as first line or second line DMT
|
NTZ (First or Second Line)
n=767 participants at risk
Natalizumab, as first line or second line DMT
|
FGL (First Line)
n=384 participants at risk
Fingolimod, first line DMT
|
TFL (First Line)
n=138 participants at risk
Teriflunomide, first line DMT
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.51%
6/1184 • Number of events 6 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.26%
1/384 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Immune system disorders
Serum sickness
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.17%
2/1184 • Number of events 2 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Hepatitis viral
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Pyrexia
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Gastrointestinal disorders
Appendicitis
|
0.17%
2/1184 • Number of events 2 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Cardiac disorders
Cardiac failure
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
2/1184 • Number of events 2 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasma malignant
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.26%
1/384 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.11%
1/884 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.72%
1/138 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Haemophilus sepsis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Encephalitis viral
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Cardiac disorders
Atrial fibrillation
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Psychiatric disorders
Completed suicide
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Pregnancy, puerperium and perinatal conditions
Abort spontaneous
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.13%
1/767 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Gastrointestinal disorders
Colitis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Abdominal abscess
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Cardiac disorders
Myocarditis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Corona virus infections
|
0.51%
6/1184 • Number of events 6 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Staphylococcal infection
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
1.4%
2/138 • Number of events 2 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.13%
1/767 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Lyme disease
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large granular lymphocytosis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Infections and infestations
Neuroborreliosis
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.26%
1/384 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.13%
1/767 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III
|
0.00%
0/1184 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.11%
1/870 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.08%
1/1184 • Number of events 1 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/884 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/97 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/870 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/767 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/384 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
0.00%
0/138 • 4 years and 9 months, during prospective data collection between 2017 and 2022
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place