Trial Outcomes & Findings for An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants (NCT NCT02761187)

NCT ID: NCT02761187

Last Updated: 2025-02-24

Results Overview

Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use.

Recruitment status

TERMINATED

Target enrollment

4253 participants

Primary outcome timeframe

Baseline up to 5 years

Results posted on

2025-02-24

Participant Flow

Participants took part in the study at 130 investigative sites in China, Taiwan, Belgium, France, Germany, Greece, Israel, Italy, Spain, Turkey, United Kingdom, Brazil, Colombia, Mexico, United States from 1 July 2016 to 30 September 2021. A total of 4253 participants were enrolled in this study.

Prospective data was collected for newly diagnosed multiple myeloma (NDMM) and Relapsed/Refractory multiple myeloma (RRMM) participants. Participants were also divided for analysis of some part of this study according to lines of therapy (LOT) they received. The final outcomes analysis performed at the end of study included 3263 participants excluding 990 participants from 4253 due to concerns around the robustness of data. Participants who received \>1 LOT were counted more than once.

Participant milestones

Participant milestones
Measure
Newly Diagnosed (ND) MM
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Relapsed/Refractory (R/R) MM
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Overall Study
STARTED
2338
1915
Overall Study
1st Line of Therapy
2193
68
Overall Study
2nd Line of Therapy
928
950
Overall Study
3rd Line of Therapy
406
1049
Overall Study
4th Line of Therapy
185
727
Overall Study
>4th Line of Therapy
153
767
Overall Study
Line of Therapy: Unknown
54
93
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
2338
1915

Reasons for withdrawal

Reasons for withdrawal
Measure
Newly Diagnosed (ND) MM
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Relapsed/Refractory (R/R) MM
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Overall Study
Too ill to Participate
13
8
Overall Study
Patient declined participation and declined follow-up for survival
34
26
Overall Study
Patient withdrew consent
64
58
Overall Study
Physician discretion
4
8
Overall Study
Change in physician or transferred to another treatment center
72
62
Overall Study
On Hospice
20
26
Overall Study
Deceased
474
642
Overall Study
Lost to Follow-up
73
63
Overall Study
Due to study discontinued at site
100
85
Overall Study
Reason not Specified
1484
937

Baseline Characteristics

Number analyzed are the number of participants available for baseline age continuous.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NDMM
n=2338 Participants
Participants with newly diagnosed MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
RRMM
n=1915 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
Total
n=4253 Participants
Total of all reporting groups
Age, Continuous
64.7 years
STANDARD_DEVIATION 10.94 • n=2337 Participants • Number analyzed are the number of participants available for baseline age continuous.
66.0 years
STANDARD_DEVIATION 10.42 • n=1914 Participants • Number analyzed are the number of participants available for baseline age continuous.
65.2 years
STANDARD_DEVIATION 10.72 • n=4251 Participants • Number analyzed are the number of participants available for baseline age continuous.
Sex: Female, Male
Female
1317 Participants
n=2338 Participants
1128 Participants
n=1915 Participants
2445 Participants
n=4253 Participants
Sex: Female, Male
Male
1021 Participants
n=2338 Participants
787 Participants
n=1915 Participants
1808 Participants
n=4253 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
348 Participants
n=2338 Participants
285 Participants
n=1915 Participants
633 Participants
n=4253 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1297 Participants
n=2338 Participants
1004 Participants
n=1915 Participants
2301 Participants
n=4253 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
693 Participants
n=2338 Participants
626 Participants
n=1915 Participants
1319 Participants
n=4253 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=2338 Participants
0 Participants
n=1915 Participants
0 Participants
n=4253 Participants
Race (NIH/OMB)
Asian
230 Participants
n=2338 Participants
160 Participants
n=1915 Participants
390 Participants
n=4253 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=2338 Participants
0 Participants
n=1915 Participants
0 Participants
n=4253 Participants
Race (NIH/OMB)
Black or African American
153 Participants
n=2338 Participants
111 Participants
n=1915 Participants
264 Participants
n=4253 Participants
Race (NIH/OMB)
White
1506 Participants
n=2338 Participants
1273 Participants
n=1915 Participants
2779 Participants
n=4253 Participants
Race (NIH/OMB)
More than one race
25 Participants
n=2338 Participants
16 Participants
n=1915 Participants
41 Participants
n=4253 Participants
Race (NIH/OMB)
Unknown or Not Reported
424 Participants
n=2338 Participants
355 Participants
n=1915 Participants
779 Participants
n=4253 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.

Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use.

Outcome measures

Outcome measures
Measure
RRMM
n=1440 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1761 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants With Co-morbidities
>5
19 Participants
38 Participants
Number of Participants With Co-morbidities
4-5
60 Participants
66 Participants
Number of Participants With Co-morbidities
Missing
50 Participants
71 Participants
Number of Participants With Co-morbidities
0-1
1064 Participants
1279 Participants
Number of Participants With Co-morbidities
2-3
247 Participants
307 Participants

PRIMARY outcome

Timeframe: At Baseline

Population: All Enrolled Population included all participants who signed the inform consent form.

Participants diagnosed with NDMM and R/RMM were determined at the start of the study.

Outcome measures

Outcome measures
Measure
RRMM
n=1915 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=2338 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)
1915 Participants
2338 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At Baseline

Population: All Enrolled Population included all participants who signed informed consent. Overall number of participants analyzed is the number of participants available for analysis.

ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry.

Outcome measures

Outcome measures
Measure
RRMM
n=1440 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1761 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Grade 0
710 Participants
714 Participants
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Grade 1
559 Participants
727 Participants
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Grade 2
113 Participants
171 Participants
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Grade 3
22 Participants
61 Participants
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Grade 4
2 Participants
13 Participants
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Missing
34 Participants
75 Participants

PRIMARY outcome

Timeframe: At Baseline

Population: All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.

Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry.

Outcome measures

Outcome measures
Measure
RRMM
n=1440 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1761 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants With Myeloma Frailty Index
0: Fit
428 Participants
517 Participants
Number of Participants With Myeloma Frailty Index
1: Intermediate
202 Participants
218 Participants
Number of Participants With Myeloma Frailty Index
≥2: Frail
130 Participants
190 Participants
Number of Participants With Myeloma Frailty Index
Missing
680 Participants
836 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At Baseline

Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\].

Outcome measures

Outcome measures
Measure
RRMM
n=686 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1790 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=458 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=249 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=80 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(4,14) · Not Done - Inferred
18 Participants
401 Participants
2 Participants
2 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(4,14) · Missing
480 Participants
108 Participants
382 Participants
213 Participants
68 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(14,16) · No
157 Participants
1007 Participants
67 Participants
27 Participants
12 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(14,16) · Not Reported/Performed
20 Participants
208 Participants
7 Participants
4 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(14,16) · Yes
7 Participants
50 Participants
0 Participants
3 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(14,16) · Not Done - Inferred
18 Participants
416 Participants
2 Participants
2 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(14,16) · Missing
484 Participants
109 Participants
382 Participants
213 Participants
68 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(4,14) · Yes
24 Participants
116 Participants
4 Participants
5 Participants
3 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(4,14) · No
144 Participants
957 Participants
63 Participants
25 Participants
9 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
Del(17p)/p53 · Missing
479 Participants
107 Participants
382 Participants
214 Participants
68 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
t(4,14) · Not Reported/Performed
20 Participants
208 Participants
7 Participants
4 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
Del(17p)/p53 · Not Reported/Performed
20 Participants
208 Participants
7 Participants
4 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
Del(17p)/p53 · Yes
23 Participants
126 Participants
12 Participants
5 Participants
0 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
Del(17p)/p53 · No
147 Participants
950 Participants
55 Participants
24 Participants
12 Participants
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
Del(17p)/p53 · Not Done - Inferred
17 Participants
399 Participants
2 Participants
2 Participants
0 Participants

PRIMARY outcome

Timeframe: At Baseline

Population: All Enrolled Population included all participants who signed informed consent. Overall number of participants are the number of participants available for analysis.

ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L).

Outcome measures

Outcome measures
Measure
RRMM
n=1440 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1761 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
R-ISS Missing
946 Participants
1170 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS Stage I
236 Participants
395 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS Stage II
267 Participants
387 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS Stage III
297 Participants
520 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS Not Available
376 Participants
138 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS Missing
264 Participants
321 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
R-ISS Stage I
40 Participants
127 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
R-ISS Stage II
145 Participants
319 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
R-ISS Stage III
24 Participants
76 Participants
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
R-ISS Not available
285 Participants
69 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. Overall number analyzed are the number of participants with data available for analyses. The data is reported as per the known line of therapies.

Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data.

Outcome measures

Outcome measures
Measure
RRMM
n=575 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1597 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=390 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=227 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=77 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Duration of Treatment for Participants With and Without Stem Cell Transplant
6.4 months
Interval 0.0 to 57.0
4.5 months
Interval 0.0 to 45.0
9.2 months
Interval 0.0 to 80.0
11.5 months
Interval 0.0 to 68.0
11.5 months
Interval 0.0 to 52.0

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.

Outcome measures

Outcome measures
Measure
RRMM
n=1331 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1790 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=1050 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=739 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=453 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Overall Survival (OS)
47.67 months
Interval 45.34 to
The upper limit of CI was not estimable due to an insufficient number of participants with events of death.
NA months
Median and 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events of death.
32.07 months
Interval 26.84 to 39.56
20.60 months
Interval 17.51 to 23.36
13.44 months
Interval 10.91 to 15.9

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Disease progression status was assessed by physician interpretation of IMWG Response criteria.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis.

Outcome measures

Outcome measures
Measure
RRMM
n=1331 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1790 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=1050 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=739 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=453 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Time to Next Therapy
15.44 months
Interval 13.63 to 17.08
30.39 months
Interval 26.87 to 33.74
9.46 months
Interval 8.34 to 10.81
6.90 months
Interval 6.11 to 7.82
5.95 months
Interval 5.16 to 6.7

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

Outcome measures

Outcome measures
Measure
RRMM
n=686 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=1790 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=458 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=249 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=80 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants With Stem Cell Transplant
686 Participants
1790 Participants
458 Participants
249 Participants
80 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed the inform consent form. Participants were reported more than once in each line of therapy. Data is reported only for 1st, 2nd 3rd and 4th line of therapy. The overall number of participants analyzed is the number of participants available for analyses.

Outcome measures

Outcome measures
Measure
RRMM
n=1685 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=2195 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=1279 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=845 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants Receiving Different Treatment Combinations
Bortezomib and Melphalan (VM)
16 Participants
75 Participants
8 Participants
3 Participants
Number of Participants Receiving Different Treatment Combinations
Lenalidomide (R)
39 Participants
21 Participants
22 Participants
5 Participants
Number of Participants Receiving Different Treatment Combinations
Daratumumab-Bortezomib (dara-V)
110 Participants
7 Participants
78 Participants
46 Participants
Number of Participants Receiving Different Treatment Combinations
Pomalidomide and Dexamethasone (PomD)
12 Participants
0 Participants
66 Participants
39 Participants
Number of Participants Receiving Different Treatment Combinations
Daratumumab (Dara)
15 Participants
0 Participants
21 Participants
56 Participants
Number of Participants Receiving Different Treatment Combinations
Bortezomib and Lenalidomide (VR)
86 Participants
560 Participants
19 Participants
10 Participants
Number of Participants Receiving Different Treatment Combinations
Bortezomib and Cyclophosphamide (VC)
99 Participants
497 Participants
43 Participants
18 Participants
Number of Participants Receiving Different Treatment Combinations
Bortezomib and Thalidomide (VT)
60 Participants
272 Participants
10 Participants
11 Participants
Number of Participants Receiving Different Treatment Combinations
Lenalidomide and Dexamethasone (RD)
218 Participants
86 Participants
126 Participants
30 Participants
Number of Participants Receiving Different Treatment Combinations
Cyclophosphamide and Thalidomide (CT)
37 Participants
60 Participants
11 Participants
5 Participants
Number of Participants Receiving Different Treatment Combinations
Melphalan and Thalidomide (MT)
3 Participants
10 Participants
4 Participants
3 Participants
Number of Participants Receiving Different Treatment Combinations
Thalidomide and Dexamethasone (TD)
1 Participants
7 Participants
5 Participants
2 Participants
Number of Participants Receiving Different Treatment Combinations
Bortezomib and dexamethasone (VD)
47 Participants
95 Participants
18 Participants
6 Participants
Number of Participants Receiving Different Treatment Combinations
Ixazomib and Lenalidomide (IR)
96 Participants
4 Participants
115 Participants
34 Participants
Number of Participants Receiving Different Treatment Combinations
Carfilzomib and Lenalidomide (KR)
112 Participants
63 Participants
42 Participants
18 Participants
Number of Participants Receiving Different Treatment Combinations
Bortezomib and Pomalidomide (VPom)
7 Participants
0 Participants
2 Participants
6 Participants
Number of Participants Receiving Different Treatment Combinations
Carfilzomib and Pomalidomide (KPom)
27 Participants
1 Participants
22 Participants
12 Participants
Number of Participants Receiving Different Treatment Combinations
Carfilzomib and dexamethasone (KD)
59 Participants
3 Participants
76 Participants
46 Participants
Number of Participants Receiving Different Treatment Combinations
Daratumumab-Ixazomib (dara-I)
12 Participants
1 Participants
7 Participants
3 Participants
Number of Participants Receiving Different Treatment Combinations
Daratumumab-Lenalidomide (dara-R)
149 Participants
3 Participants
70 Participants
31 Participants
Number of Participants Receiving Different Treatment Combinations
Daratumumab-Pomalidomide (dara-Pom)
49 Participants
0 Participants
72 Participants
43 Participants
Number of Participants Receiving Different Treatment Combinations
Ixazomib and Dexamethasone (ID)
14 Participants
1 Participants
13 Participants
9 Participants
Number of Participants Receiving Different Treatment Combinations
Ixazomib (I)
6 Participants
0 Participants
5 Participants
4 Participants
Number of Participants Receiving Different Treatment Combinations
Elotuzumab and Lenalidomide (Elo-R)
42 Participants
7 Participants
20 Participants
10 Participants
Number of Participants Receiving Different Treatment Combinations
Elotuzumab-Pomalidomide (Elo-Pom)
6 Participants
0 Participants
10 Participants
14 Participants
Number of Participants Receiving Different Treatment Combinations
Elotuzumab-Other Regimen (Elo-Other)
4 Participants
6 Participants
4 Participants
1 Participants
Number of Participants Receiving Different Treatment Combinations
Other Regimen
359 Participants
416 Participants
390 Participants
380 Participants

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed informed consent. Participants were reported more than once in each line of therapy. Data is reported only for 1st, 2nd and 3rd line of therapy.

Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy.

Outcome measures

Outcome measures
Measure
RRMM
n=2748 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=4224 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=1734 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Treatment Sequencing
mAB/PI based
119 Participants
156 Participants
69 Participants
Number of Treatment Sequencing
PI/alkylator based
137 Participants
351 Participants
57 Participants
Number of Treatment Sequencing
IMID/alkylator based
119 Participants
123 Participants
57 Participants
Number of Treatment Sequencing
mAB based
77 Participants
41 Participants
129 Participants
Number of Treatment Sequencing
mAB/IMID based
213 Participants
290 Participants
128 Participants
Number of Treatment Sequencing
mAB/alkalytor based
7 Participants
2 Participants
6 Participants
Number of Treatment Sequencing
mAB/IMID/PI based
14 Participants
36 Participants
12 Participants
Number of Treatment Sequencing
Cytotoxic
59 Participants
74 Participants
49 Participants
Number of Treatment Sequencing
IMID based
361 Participants
515 Participants
118 Participants
Number of Treatment Sequencing
PI based
204 Participants
366 Participants
101 Participants
Number of Treatment Sequencing
Alkylator based
40 Participants
79 Participants
33 Participants
Number of Treatment Sequencing
PI/IMID based
295 Participants
608 Participants
115 Participants
Number of Treatment Sequencing
PI/IMID/alkylator based
14 Participants
34 Participants
7 Participants
Number of Treatment Sequencing
Other
32 Participants
59 Participants
46 Participants
Number of Treatment Sequencing
Unknown
1057 Participants
1490 Participants
807 Participants

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: All Enrolled Population included all participants who signed informed consent. Participants received more than one LOT and are counted in more than one LOT. The data is reported as per the known line of therapies. Participants were counted multiple times in different categories. The overall number of participants analyzed is the number of participants available for analyses.

Outcome measures

Outcome measures
Measure
RRMM
n=1878 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=2260 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=1416 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=700 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=500 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Reasons for Treatment Modifications
COVID-19 Restrictions
21 Participants
13 Participants
22 Participants
11 Participants
8 Participants
Reasons for Treatment Modifications
Adverse Event Related to Drug
676 Participants
920 Participants
459 Participants
240 Participants
187 Participants
Reasons for Treatment Modifications
Other
333 Participants
425 Participants
248 Participants
110 Participants
81 Participants
Reasons for Treatment Modifications
Planned Change
274 Participants
386 Participants
205 Participants
99 Participants
62 Participants
Reasons for Treatment Modifications
Adverse Event Not Related to MM Therapy Drug
243 Participants
234 Participants
179 Participants
91 Participants
62 Participants
Reasons for Treatment Modifications
Current Dose Tolerated, Dose Increased
107 Participants
110 Participants
105 Participants
47 Participants
30 Participants
Reasons for Treatment Modifications
Dose Delay Due to Toxicity
91 Participants
63 Participants
65 Participants
32 Participants
22 Participants
Reasons for Treatment Modifications
Patient/Family Preference
58 Participants
53 Participants
39 Participants
19 Participants
16 Participants
Reasons for Treatment Modifications
Treatment Fatigue
36 Participants
25 Participants
33 Participants
17 Participants
13 Participants
Reasons for Treatment Modifications
Lack of Response
23 Participants
16 Participants
27 Participants
11 Participants
13 Participants
Reasons for Treatment Modifications
Relapse - Biochemical Progression
17 Participants
9 Participants
19 Participants
11 Participants
7 Participants
Reasons for Treatment Modifications
COVID-19 Diagnosis (Confirmed Positive)
11 Participants
5 Participants
7 Participants
8 Participants
3 Participants
Reasons for Treatment Modifications
Relapse - Symptomatic/Clinical Progression
10 Participants
5 Participants
3 Participants
2 Participants
3 Participants
Reasons for Treatment Modifications
COVID-19 Diagnosis (Suspected Positive)
0 Participants
3 Participants
1 Participants
0 Participants
0 Participants
Reasons for Treatment Modifications
Missing
13 Participants
6 Participants
4 Participants
2 Participants
1 Participants

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: As the study was early terminated data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: Participants who received Takeda products and signed informed consent form were included in the analysis. As pre-specified in SAP, data for treatment-emergent adverse events was planned to be collected and reported for Takeda products only. Participants were counted more than once in each line of therapy towards the total. The data is reported as per the known line of therapies.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.

Outcome measures

Outcome measures
Measure
RRMM
n=1878 Participants
Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
NDMM
n=2261 Participants
Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
3rd Line of Therapy
n=1455 Participants
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=912 Participants
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=500 Participants
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Unknown
Missing line of therapy with respect to recorded regimen or have not observed any regimen with line of therapy on or after study entry. Participants were observed until study discontinuation, death or end of study (up to approximately 5 years).
Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation
275 Participants
375 Participants
178 Participants
98 Participants
95 Participants

Adverse Events

1st Line of Therapy

Serious events: 269 serious events
Other events: 306 other events
Deaths: 351 deaths

2nd Line of Therapy

Serious events: 101 serious events
Other events: 125 other events
Deaths: 418 deaths

3rd Line of Therapy

Serious events: 82 serious events
Other events: 79 other events
Deaths: 420 deaths

4th Line of Therapy

Serious events: 43 serious events
Other events: 39 other events
Deaths: 348 deaths

>4th Line of Therapy

Serious events: 38 serious events
Other events: 32 other events
Deaths: 234 deaths

Robustness Concerns: 1st Line of Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 58 deaths

Robustness Concerns: 2nd Line of Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 72 deaths

Robustness Concerns: 3rd Line of Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 65 deaths

Robustness Concerns: 4th Line of Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 32 deaths

Robustness Concerns: >4th Line of Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Robustness Concerns: Unknown Line of Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 28 deaths

Serious adverse events

Serious adverse events
Measure
1st Line of Therapy
n=1849 participants at risk
The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
2nd Line of Therapy
n=773 participants at risk
The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
3rd Line of Therapy
n=455 participants at risk
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=239 participants at risk
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=181 participants at risk
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Robustness Concerns: 1st Line of Therapy
The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 1st line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: 2nd Line of Therapy
The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 2nd line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: 3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 3rd line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: 4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 4th line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: >4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in \>4th line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: Unknown Line of Therapy
The 'Unknown Line of Therapy' indicates either: 1) participant was on a regimen on or after study entry, but missing line of therapy with respect to that regimen or 2) have not observed any regimen with line of therapy on or after study entry. Only participants in unknown line of therapy with concerns around the robustness of data were included in this arm.
Blood and lymphatic system disorders
Febrile neutropenia
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Anaemia
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
3/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Febrile bone marrow aplasia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Haematotoxicity
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Neutropenia
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Pancytopenia
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Thrombocytopenia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.88%
4/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
4/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.2%
4/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Acute myocardial infarction
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Angina pectoris
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Atrial fibrillation
0.38%
7/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.2%
4/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Atrial flutter
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Chest pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Bradycardia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac arrest
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac failure
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac failure acute
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac failure congestive
0.49%
9/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac flutter
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiogenic shock
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiomyopathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Coronary artery disease
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Coronary artery stenosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Coronary artery thrombosis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Microvascular coronary artery disease
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Myocardial infarction
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Pericardial effusion
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Pericarditis
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Restrictive cardiomyopathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Supraventricular tachycardia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Systolic dysfunction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Endocrine disorders
Parathyroid disorder
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Abdominal pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Abdominal pain upper
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Colitis
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Constipation
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Diarrhoea
0.43%
8/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Diverticular perforation
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Enteritis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Enterocolitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Intestinal perforation
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Large intestine perforation
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Nausea
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Pancreatic duct obstruction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Small intestinal obstruction
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Stomatitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Vomiting
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Asthenia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Death
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Disease progression
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Fatigue
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
General physical health deterioration
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Generalised oedema
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Hyperthermia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Influenza like illness
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Malaise
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Non-cardiac chest pain
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Oedema peripheral
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Pyrexia
0.54%
10/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.88%
4/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Biliary obstruction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Cholecystitis acute
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Gallbladder volvulus
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Jaundice
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Immune system disorders
Cytokine release syndrome
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Abdominal sepsis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Abscess limb
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Atypical pneumonia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Bronchitis
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Bronchopulmonary aspergillosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Bursitis infective
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
COVID-19
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
COVID-19 pneumonia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Cellulitis
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Cellulitis of male external genital organ
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Clostridium difficile colitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Cytomegalovirus infection reactivation
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Device related infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Diarrhoea infectious
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Diverticulitis
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Ear infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Endocarditis bacterial
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Enterococcal bacteraemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Intestinal sepsis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Enterococcal sepsis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Escherichia bacteraemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Febrile infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Gastroenteritis
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Gastroenteritis viral
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Gastrointestinal infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Groin abscess
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Herpes zoster
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Influenza
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Kidney infection
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Klebsiella infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Lower respiratory tract infection
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.8%
8/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Meningitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Meningoencephalitis herpetic
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Metapneumovirus infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Osteomyelitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Parotitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumocystis jirovecii pneumonia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia
2.3%
42/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.2%
17/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
3.7%
17/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.1%
5/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
3/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia bacterial
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia influenzal
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia parainfluenzae viral
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia pneumococcal
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia viral
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Postoperative wound infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pyelonephritis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Respiratory syncytial virus infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Respiratory tract infection
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.65%
5/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Respiratory tract infection viral
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Rhinitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Sepsis
0.43%
8/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.52%
4/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Sepsis syndrome
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Septic shock
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Staphylococcal infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Staphylococcal sepsis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Streptococcal sepsis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Systemic candida
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Upper respiratory tract infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Loss of consciousness
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Urinary tract infection
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.3%
3/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Urosepsis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Viral upper respiratory tract infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Accidental overdose
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Ankle fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Fall
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Femur fracture
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Hip fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Humerus fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Limb injury
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Lower limb fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Osteochondral fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Pelvic fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Post procedural fever
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Postoperative respiratory distress
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Tibia fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Toxicity to various agents
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Blood creatinine increased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Cardiac murmur
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Ejection fraction decreased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Human metapneumovirus test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Influenza A virus test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Liver function test increased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Platelet count decreased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Respirovirus test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Rotavirus test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Rubulavirus test positive
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
SARS-CoV-2 test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Troponin increased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
White blood cell count decreased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Dehydration
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Fluid retention
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hyperkalaemia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypocalcaemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypoglycaemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypokalaemia
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hyponatraemia
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypovolaemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Back pain
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Bone pain
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Chest wall haematoma
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Myalgia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Osteolysis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Osteonecrosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Spinal pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.88%
4/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
3/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Autonomic neuropathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Balance disorder
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Cerebral infarction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Cerebrovascular accident
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.52%
4/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Dizziness
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Dysarthria
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Embolic cerebral infarction
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Embolic stroke
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Encephalopathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Haemorrhagic stroke
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Headache
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Nervous system disorder
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Neuropathy peripheral
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Paraesthesia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Paralysis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Parkinson's disease
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Post stroke seizure
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Radiculopathy
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Seizure
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Somnolence
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Syncope
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Transient ischaemic attack
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Unresponsive to stimuli
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Product Issues
Device loosening
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Acute psychosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Confusional state
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Delirium
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Mental disorder
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Mental status changes
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Acute kidney injury
0.54%
10/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.88%
4/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
4/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Calculus urinary
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Chronic kidney disease
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Proteinuria
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Renal failure
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Renal impairment
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Urinary incontinence
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Urinary retention
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Chylothorax
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.52%
4/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
3/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Drug eruption
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash macular
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash pruritic
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Surgical and medical procedures
Toe amputation
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Deep vein thrombosis
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Embolism
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Hypotension
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Orthostatic hypotension
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Subclavian vein thrombosis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.

Other adverse events

Other adverse events
Measure
1st Line of Therapy
n=1849 participants at risk
The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
2nd Line of Therapy
n=773 participants at risk
The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
3rd Line of Therapy
n=455 participants at risk
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
4th Line of Therapy
n=239 participants at risk
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
>4th Line of Therapy
n=181 participants at risk
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
Robustness Concerns: 1st Line of Therapy
The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 1st line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: 2nd Line of Therapy
The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 2nd line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: 3rd Line of Therapy
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 3rd line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: 4th Line of Therapy
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 4th line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: >4th Line of Therapy
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in \>4th line of therapy with concerns around the robustness of data were included in this arm.
Robustness Concerns: Unknown Line of Therapy
The 'Unknown Line of Therapy' indicates either: 1) participant was on a regimen on or after study entry, but missing line of therapy with respect to that regimen or 2) have not observed any regimen with line of therapy on or after study entry. Only participants in unknown line of therapy with concerns around the robustness of data were included in this arm.
Blood and lymphatic system disorders
Anaemia
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
5/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
3/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Anaemia of malignant disease
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Cytopenia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Haematotoxicity
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Leukocytosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Leukopenia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Neutropenia
0.87%
16/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.3%
3/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
3/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Pancytopenia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Blood and lymphatic system disorders
Thrombocytopenia
0.65%
12/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.8%
14/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
3.1%
14/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.7%
4/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
4.4%
8/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Angina pectoris
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Atrial fibrillation
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Bradycardia
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac failure
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiac failure congestive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Cardiomyopathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Diastolic dysfunction
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Palpitations
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Sinus tachycardia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Systolic dysfunction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Tachycardia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Cardiac disorders
Ventricular extrasystoles
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Ear and labyrinth disorders
Deafness unilateral
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Ear and labyrinth disorders
Ear pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Ear and labyrinth disorders
Tinnitus
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Ear and labyrinth disorders
Vertigo
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Blepharitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Dacryoadenitis acquired
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Eyelid oedema
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Hypermetropia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Myopia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Periorbital oedema
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Retinal disorder
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Vision blurred
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Eye disorders
Visual acuity reduced
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Abdominal distension
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Abdominal pain
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Abdominal pain upper
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Aerophagia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Anal dilatation
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Anal fissure
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Colitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Constipation
0.70%
13/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.91%
7/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Diarrhoea
1.3%
24/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.8%
14/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.9%
13/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.1%
5/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Diarrhoea haemorrhagic
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Dry mouth
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Gastritis erosive
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Gastrointestinal disorder
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Haematochezia
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Haemorrhoids
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Irritable bowel syndrome
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Nausea
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.5%
7/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Odynophagia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Pancreatitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Stomatitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Gastrointestinal disorders
Vomiting
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Immune system disorders
Hypersensitivity
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Asthenia
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.52%
4/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Chest pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Discomfort
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Fatigue
1.4%
25/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.3%
10/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.8%
8/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.1%
5/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
General physical health deterioration
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Hyperpyrexia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Influenza like illness
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Injection site pruritus
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Injection site rash
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Injection site reaction
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Malaise
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Non-cardiac chest pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Oedema peripheral
0.59%
11/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.52%
4/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.88%
4/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Peripheral swelling
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
General disorders
Pyrexia
0.43%
8/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Hepatomegaly
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Hepatobiliary disorders
Hyperbilirubinaemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Immune system disorders
Immunosuppression
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Immune system disorders
Oral allergy syndrome
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Bronchitis
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Candida sepsis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Catheter site infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Conjunctivitis
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Cystitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Cytomegalovirus infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Diverticulitis
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Eyelid infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Gastroenteritis
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Groin infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Herpes virus infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Herpes zoster
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Influenza
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Klebsiella infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Lower respiratory tract infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Lymph gland infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Oral infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pharyngitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pneumonia
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.78%
6/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Postoperative wound infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pseudomonal bacteraemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Pustule
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Respiratory syncytial virus infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Respiratory tract infection
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Sinusitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Tinea versicolour
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Tongue fungal infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Tooth abscess
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Upper respiratory tract infection
0.43%
8/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Urinary tract infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Viral infection
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Concussion
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Contusion
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Fall
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Femur fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Limb injury
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Rib fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Spinal compression fracture
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Toxicity to various agents
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Adenovirus test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Alanine aminotransferase increased
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Aspartate aminotransferase increased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Blood creatinine increased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Blood glucose increased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Haemoglobin decreased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Hepatic enzyme increased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Hepatitis E virus test positive
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Lymphocyte count decreased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Neutrophil count decreased
0.27%
5/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Platelet count decreased
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Transaminases increased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Weight decreased
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
Weight increased
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Investigations
White blood cell count decreased
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Decreased appetite
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Dehydration
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hyperglycaemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hyperkalaemia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Malnutrition
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Steroid diabetes
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Arthralgia
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Back pain
0.49%
9/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Bone pain
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Coccydynia
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Joint swelling
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Myalgia
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Myopathy
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Autonomic neuropathy
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Balance disorder
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Burning sensation
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Depressed level of consciousness
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Dizziness
0.43%
8/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Dysaesthesia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Dysarthria
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Formication
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Headache
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Hypoaesthesia
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Lumbosacral radiculopathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Neuralgia
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Neuropathy peripheral
3.5%
64/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
4.0%
31/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
3.3%
15/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
2.5%
6/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
3.9%
7/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Neurotoxicity
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Paraesthesia
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Peripheral sensorimotor neuropathy
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Peripheral sensory neuropathy
2.3%
43/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.2%
9/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.66%
3/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.3%
3/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Polyneuropathy
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Somnolence
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Syncope
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Nervous system disorders
Tremor
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Affect lability
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Agitation
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Anxiety
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Depression
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Insomnia
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.39%
3/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Mental status changes
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Mood altered
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Mood swings
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Psychiatric disorders
Nervousness
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Acute kidney injury
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Cystitis noninfective
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Renal failure
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Renal impairment
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.84%
2/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Renal and urinary disorders
Urethral obstruction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Reproductive system and breast disorders
Pelvic pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Reproductive system and breast disorders
Penile erythema
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Reproductive system and breast disorders
Testicular pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Cough
0.32%
6/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Acne
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Dermatitis bullous
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Drug eruption
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Ecchymosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Erythema
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Erythema multiforme
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Night sweats
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Pruritus
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash
0.54%
10/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
1.1%
2/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash erythematous
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash macular
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.38%
7/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash maculovesicular
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash pruritic
0.22%
4/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Rash vesicular
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Skin mass
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Skin reaction
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Skin ulcer
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Skin and subcutaneous tissue disorders
Urticaria
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Circulatory collapse
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Deep vein thrombosis
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Hypertension
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Hypotension
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Orthostatic hypotension
0.16%
3/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.26%
2/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.44%
2/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.55%
1/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Thrombophlebitis
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Vasculitis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Vascular disorders
Venous thrombosis limb
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Myositis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.22%
1/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Osteonecrosis
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.54%
10/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.13%
1/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.42%
1/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.11%
2/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
Musculoskeletal and connective tissue disorders
Spinal pain
0.05%
1/1849 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/773 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/455 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/239 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0.00%
0/181 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
0/0 • From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Results disclosure agreements

  • Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
  • Publication restrictions are in place

Restriction type: OTHER