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.
TERMINATED
4253 participants
Baseline up to 5 years
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
| 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
| 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
| 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 yearsPopulation: 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
| 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 BaselinePopulation: 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
| 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 yearsPopulation: 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 yearsPopulation: As the study was early terminated data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At BaselinePopulation: 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
| 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 BaselinePopulation: 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
| 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 yearsPopulation: 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 yearsPopulation: As the study was early terminated data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At BaselinePopulation: 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
| 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 BaselinePopulation: 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
| 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 yearsPopulation: 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
| 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 yearsPopulation: 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
| 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 yearsPopulation: 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 yearsPopulation: 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 yearsPopulation: 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
| 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 yearsPopulation: 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
| 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 yearsPopulation: 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 yearsPopulation: 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
| 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 yearsPopulation: 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
| 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 yearsPopulation: 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 yearsPopulation: 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 yearsPopulation: 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 yearsPopulation: 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 yearsPopulation: 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
| 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 yearsPopulation: 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 yearsPopulation: 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 yearsPopulation: 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 yearsPopulation: 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
| 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
2nd Line of Therapy
3rd Line of Therapy
4th Line of Therapy
>4th Line of Therapy
Robustness Concerns: 1st Line of Therapy
Robustness Concerns: 2nd Line of Therapy
Robustness Concerns: 3rd Line of Therapy
Robustness Concerns: 4th Line of Therapy
Robustness Concerns: >4th Line of Therapy
Robustness Concerns: Unknown Line of Therapy
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
| 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
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